Ligelizumab (QGE031)
|
1/14/2021
|
|
Treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment.
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/14/2021/2021
Approval Date: |
Indication: Treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment. |
Category: Rare Inherited Disorders |
|
APL-106 (uproleselan)
|
1/07/2021
|
|
Treatment of relapsed/refractory acute myeloid leukemia (AML).
|
Cancer
|
|
Date of BT Designation Disclosure: 1/07/2021/2021
Approval Date: |
Indication: Treatment of relapsed/refractory acute myeloid leukemia (AML). |
Category: Cancer |
|
Chiauranib
|
1/05/2021
|
|
"Treatment of patients with small cell lung cancer (SCLC) with disease progression or recurrence after two lines of prior systematic chemotherapy. "
|
Cancer
|
|
Date of BT Designation Disclosure: 1/05/2021/2021
Approval Date: |
Indication: "Treatment of patients with small cell lung cancer (SCLC) with disease progression or recurrence after two lines of prior systematic chemotherapy. " |
Category: Cancer |
|
Tiragolumab in combination with Tecentriq
|
1/05/2021
|
|
First-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations
|
Cancer
|
|
Date of BT Designation Disclosure: 1/05/2021/2021
Approval Date: |
Indication: First-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations |
Category: Cancer |
|
CNCT19 (CD19 CAR-T)
|
12/23/2020
|
|
A potential CD19 CAR-T therapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
|
Cancer
|
|
Date of BT Designation Disclosure: 12/23/2020/2020
Approval Date: |
Indication: A potential CD19 CAR-T therapy for the treatment of adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) |
Category: Cancer |
|
IO102 and IO103 with anti-PD-1 mAb
|
12/15/2020
|
|
Patients with unresectable/ metastatic melanoma
|
Cancer
|
|
Date of BT Designation Disclosure: 12/15/2020/2020
Approval Date: |
Indication: Patients with unresectable/ metastatic melanoma |
Category: Cancer |
|
IO102 and IO103 with anti-PD-1 mAb
|
12/15/2020
|
|
Patients with unresectable/ metastatic melanoma
|
Cancer
|
|
Date of BT Designation Disclosure: 12/15/2020/2020
Approval Date: |
Indication: Patients with unresectable/ metastatic melanoma |
Category: Cancer |
|
CUTX-101 (Copper Histidinate)
|
12/15/2020
|
|
Treatment of Menkes Disease
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 12/15/2020/2020
Approval Date: |
Indication: Treatment of Menkes Disease |
Category: Rare Inherited Disorders |
|
Pegloprastide (AVB-620)
|
12/14/2020
|
|
Intraoperative detection and visualization of positive margins during breast cancer surgery.
|
Cancer
|
|
Date of BT Designation Disclosure: 12/14/2020/2020
Approval Date: |
Indication: Intraoperative detection and visualization of positive margins during breast cancer surgery. |
Category: Cancer |
|
Sotorasib
|
12/08/2020
|
|
Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy.
|
Cancer
|
|
Date of BT Designation Disclosure: 12/08/2020/2020
Approval Date: |
Indication: Treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, as determined by an FDA-approved test, following at least one prior systemic therapy. |
Category: Cancer |
|
Repotrectinib
|
12/08/2020
|
|
"Treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI-naïve). "
|
Cancer
|
|
Date of BT Designation Disclosure: 12/08/2020/2020
Approval Date: |
Indication: "Treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI-naïve). " |
Category: Cancer |
|
Zanidatamab
|
11/30/2020
|
|
Treatment for patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC).
|
Cancer
|
|
Date of BT Designation Disclosure: 11/30/2020/2020
Approval Date: |
Indication: Treatment for patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC). |
Category: Cancer |
|
Zanidatamab
|
11/30/2020
|
|
Treatment for patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC).
|
Cancer
|
|
Date of BT Designation Disclosure: 11/30/2020/2020
Approval Date: |
Indication: Treatment for patients with previously-treated HER2 gene-amplified biliary tract cancer (BTC). |
Category: Cancer |
|
Vixarelimab
|
11/16/2020
|
|
Treatment of pruritus associated with prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules
|
Other
|
|
Date of BT Designation Disclosure: 11/16/2020/2020
Approval Date: |
Indication: Treatment of pruritus associated with prurigo nodularis, a chronic inflammatory skin condition characterized by severely pruritic skin nodules |
Category: Other |
|
Olorofim
|
10/22/2020
|
|
Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 10/22/2020/2020
Approval Date: |
Indication: Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy |
Category: Infectious Disease |
|
Lanifibranor
|
10/12/2020
|
|
Treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS)
|
Other
|
|
Date of BT Designation Disclosure: 10/12/2020/2020
Approval Date: |
Indication: Treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) |
Category: Other |
|
IMGN632
|
10/05/2020
|
|
Treatment of relapsed or refractory blastic plasmacytoid dendritic cell neoplasm
|
Cancer
|
|
Date of BT Designation Disclosure: 10/05/2020/2020
Approval Date: |
Indication: Treatment of relapsed or refractory blastic plasmacytoid dendritic cell neoplasm |
Category: Cancer |
|
Farxiga® (dapagliflozin)
|
10/02/2020
|
|
Patients with chronic kidney disease (CKD), with and without type 2 diabetes (T2D)
|
Other
|
|
Date of BT Designation Disclosure: 10/02/2020/2020
Approval Date: |
Indication: Patients with chronic kidney disease (CKD), with and without type 2 diabetes (T2D) |
Category: Other |
|
AXS-12
|
8/05/2020
|
|
Treatment of cataplexy in patients with narcolepsy.
|
Other
|
|
Date of BT Designation Disclosure: 8/05/2020/2020
Approval Date: |
Indication: Treatment of cataplexy in patients with narcolepsy. |
Category: Other |
|
Tagrisso (osimertinib)
|
7/30/2020
|
12/18/2020
|
Adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent.
|
Cancer
|
|
Date of BT Designation Disclosure: 7/30/2020/2020
Approval Date: 2020 |
Indication: Adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. |
Category: Cancer |
|
Pevonedistat
|
7/30/2020
|
|
Treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS)
|
Cancer
|
|
Date of BT Designation Disclosure: 7/30/2020/2020
Approval Date: |
Indication: Treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS) |
Category: Cancer |
|
MK-6482
|
7/29/2020
|
|
Treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
|
Cancer
|
|
Date of BT Designation Disclosure: 7/29/2020/2020
Approval Date: |
Indication: Treatment of patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC) with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required. |
Category: Cancer |
|
Mavacamten (MYK-461)
|
7/23/2020
|
|
Treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM).
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 7/23/2020/2020
Approval Date: |
Indication: Treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM). |
Category: Rare Inherited Disorders |
|
CD20xCD3
|
7/14/2020
|
|
Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies
|
Cancer
|
|
Date of BT Designation Disclosure: 7/14/2020/2020
Approval Date: |
Indication: Treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma who have received at least two prior systemic therapies |
Category: Cancer |
|
CTP-543
|
7/08/2020
|
|
Treatment of Alopecia Areata
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 7/08/2020/2020
Approval Date: |
Indication: Treatment of Alopecia Areata |
Category: Rare Inherited Disorders |
|
ER-004
|
7/06/2020
|
|
Investigational Prenatal Treatment ER-004 In X-Linked Hypohidrotic Ectodermal Dysplasia
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 7/06/2020/2020
Approval Date: |
Indication: Investigational Prenatal Treatment ER-004 In X-Linked Hypohidrotic Ectodermal Dysplasia |
Category: Rare Inherited Disorders |
|
TLX250-CDX
|
7/01/2020
|
|
Renal cancer imaging product
|
Cancer
|
|
Date of BT Designation Disclosure: 7/01/2020/2020
Approval Date: |
Indication: Renal cancer imaging product |
Category: Cancer |
|
AXS-05
|
6/26/2020
|
|
Treatment of Alzheimer’s disease agitation, major depressive disorder, and other central nervous system (CNS) disorders
|
Other
|
|
Date of BT Designation Disclosure: 6/26/2020/2020
Approval Date: |
Indication: Treatment of Alzheimer’s disease agitation, major depressive disorder, and other central nervous system (CNS) disorders |
Category: Other |
|
Brensocatib
|
6/18/2020
|
|
Treatment for bronchiectasis
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 6/18/2020/2020
Approval Date: |
Indication: Treatment for bronchiectasis |
Category: Rare Inherited Disorders |
|
Brensocatib (INS1007)
|
6/08/2020
|
|
Treatment of bronchiectasis and other inflammatory diseases and of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbation
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 6/08/2020/2020
Approval Date: |
Indication: Treatment of bronchiectasis and other inflammatory diseases and of adult patients with non-cystic fibrosis bronchiectasis (NCFBE) for reducing exacerbation |
Category: Rare Inherited Disorders |
|
HSV Pritelivir (AIC316)
|
6/05/2020
|
|
Treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised adults
|
Other
|
|
Date of BT Designation Disclosure: 6/05/2020/2020
Approval Date: |
Indication: Treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised adults |
Category: Other |
|
Neuromodulation therapy (NTX100)
|
6/02/2020
|
|
Treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications
|
Other
|
|
Date of BT Designation Disclosure: 6/02/2020/2020
Approval Date: |
Indication: Treatment of adults with primary moderate-severe Restless Legs Syndrome (RLS) who are refractory to medications |
Category: Other |
|
Enhertu (trastuzumab deruxtecan)
|
5/11/2020
|
1/18/2021
|
Treatment of adult patients with previously treated HER2 positive advanced gastric cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 5/11/2020/2020
Approval Date: 2021 |
Indication: Treatment of adult patients with previously treated HER2 positive advanced gastric cancer |
Category: Cancer |
|
Bavencio (avelumab)
|
4/09/2020
|
7/01/2020
|
Patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 4/09/2020/2020
Approval Date: 2020 |
Indication: Patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy |
Category: Cancer |
|
Sotatercept
|
4/08/2020
|
|
Patients with pulmonary arterial hypertension
|
Cardiovascular
|
|
Date of BT Designation Disclosure: 4/08/2020/2020
Approval Date: |
Indication: Patients with pulmonary arterial hypertension |
Category: Cardiovascular |
|
Baricitinib
|
3/16/2020
|
|
Patients with alopecia areata
|
Other
|
|
Date of BT Designation Disclosure: 3/16/2020/2020
Approval Date: |
Indication: Patients with alopecia areata |
Category: Other |
|
JNJ-6372
|
3/10/2020
|
|
Patients with EGFR-positive metastatic non-small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 3/10/2020/2020
Approval Date: |
Indication: Patients with EGFR-positive metastatic non-small cell lung cancer who harbor exon 20 insertion mutations, and whose disease has progressed on or after platinum-based chemotherapy |
Category: Cancer |
|
Yervoy (ipilimumab)
|
3/10/2020
|
|
In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
|
Cancer
|
|
Date of BT Designation Disclosure: 3/10/2020/2020
Approval Date: |
Indication: In combination with nivolumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
Category: Cancer |
|
Esbriet (pirfenidone)
|
3/03/2020
|
|
Patients with unclassifiable interstitial lung disease
|
Other
|
|
Date of BT Designation Disclosure: 3/03/2020/2020
Approval Date: |
Indication: Patients with unclassifiable interstitial lung disease |
Category: Other |
|
Exebacase
|
2/24/2020
|
|
Patients with MRSA bacteremia, including right-sided endocarditis, when used in conjunction with standard of care antibiotics
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 2/24/2020/2020
Approval Date: |
Indication: Patients with MRSA bacteremia, including right-sided endocarditis, when used in conjunction with standard of care antibiotics |
Category: Infectious Disease |
|
Padcev
|
2/20/2020
|
|
In combination with Keytruda for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting
|
Cancer
|
|
Date of BT Designation Disclosure: 2/20/2020/2020
Approval Date: |
Indication: In combination with Keytruda for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting |
Category: Cancer |
|
APR-246
|
1/30/2020
|
|
Treatment of patients with myelodysplastic syndromes with a susceptible TP53 mutation
|
Cancer
|
|
Date of BT Designation Disclosure: 1/30/2020/2020
Approval Date: |
Indication: Treatment of patients with myelodysplastic syndromes with a susceptible TP53 mutation |
Category: Cancer |
|
Artesunate
|
2020
|
5/26/2020
|
Initial treatment of severe malaria in adult and pediatric patients
|
Other
|
|
Date of BT Designation Disclosure: 2020/2020
Approval Date: 2020 |
Indication: Initial treatment of severe malaria in adult and pediatric patients |
Category: Other |
|
TEPEZZA (TEPROTUMUMABTRBW)
|
2020
|
1/21/2020
|
Treatment of thyroid eye disease
|
Other
|
|
Date of BT Designation Disclosure: 2020/2020
Approval Date: 2020 |
Indication: Treatment of thyroid eye disease |
Category: Other |
|
Qinlock (Ripretinib)
|
2020
|
5/15/2020
|
Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib
|
Cancer
|
|
Date of BT Designation Disclosure: 2020/2020
Approval Date: 2020 |
Indication: Treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib |
Category: Cancer |
|
Pemazyre (pemigatinib)
|
2020
|
2020
|
Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test
|
Cancer
|
|
Date of BT Designation Disclosure: 2020/2020
Approval Date: 2020 |
Indication: Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test |
Category: Cancer |
|
Opdivo (nivolumab)
|
2020
|
3/10/2020
|
In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
|
Cancer
|
|
Date of BT Designation Disclosure: 2020/2020
Approval Date: 2020 |
Indication: In combination with ipilimumab, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
Category: Cancer |
|
B38M (JNJ‐4528)
|
12/06/2019
|
|
Patients with previously treated multiple myeloma
|
Cancer
|
|
Date of BT Designation Disclosure: 12/06/2019/2019
Approval Date: |
Indication: Patients with previously treated multiple myeloma |
Category: Cancer |
|
Rilonacept
|
11/20/2019
|
|
Treatment of recurrent pericarditis
|
Cardiovascular
|
|
Date of BT Designation Disclosure: 11/20/2019/2019
Approval Date: |
Indication: Treatment of recurrent pericarditis |
Category: Cardiovascular |
|
Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn)
|
11/19/2019
|
10/14/2020
|
Treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 11/19/2019/2019
Approval Date: 2020 |
Indication: Treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients |
Category: Infectious Disease |
|
Olorofim (F901318)
|
11/13/2019
|
|
Treatment of invasive mold infections in patients w limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, & infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species
|
Other
|
|
Date of BT Designation Disclosure: 11/13/2019/2019
Approval Date: |
Indication: Treatment of invasive mold infections in patients w limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, & infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species |
Category: Other |
|
Ofev (nintedanib)
|
10/10/2019
|
3/09/2020
|
Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 10/10/2019/2019
Approval Date: 2020 |
Indication: Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype |
Category: Rare Inherited Disorders |
|
Zejula (niraparib)
|
10/03/2019
|
|
Patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer (CRPC) who have previously received taxane chemotherapy and androgen receptor (AR)–targeted therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/03/2019/2019
Approval Date: |
Indication: Patients with BRCA1/2-mutated metastatic castration-resistant prostate cancer (CRPC) who have previously received taxane chemotherapy and androgen receptor (AR)–targeted therapy |
Category: Cancer |
|
Cotellic (cobimetinib)
|
10/03/2019
|
|
Adult patients with histiocytic neoplasms who do not harbor a BRAF V600 mutation
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 10/03/2019/2019
Approval Date: |
Indication: Adult patients with histiocytic neoplasms who do not harbor a BRAF V600 mutation |
Category: Rare Inherited Disorders |
|
tepotinib
|
9/11/2019
|
|
Patients with metastatic non-small cell lung cancer (NSCLC) harboring a MET exon 14 skipping alteration who have progressed following platinum-based chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 9/11/2019/2019
Approval Date: |
Indication: Patients with metastatic non-small cell lung cancer (NSCLC) harboring a MET exon 14 skipping alteration who have progressed following platinum-based chemotherapy |
Category: Cancer |
|
EBANGA ANSUVIMAB-ZYKL
|
9/06/2019
|
12/21/2020
|
Treatment for Ebola
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 9/06/2019/2019
Approval Date: 2020 |
Indication: Treatment for Ebola |
Category: Infectious Disease |
|
TABRECTA (capmatinib)
|
9/06/2019
|
5/06/2020
|
Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test
|
Cancer
|
|
Date of BT Designation Disclosure: 9/06/2019/2019
Approval Date: 2020 |
Indication: Treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test |
Category: Cancer |
|
Nirogacestat
|
8/29/2019
|
|
Adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis
|
Cancer
|
|
Date of BT Designation Disclosure: 8/29/2019/2019
Approval Date: |
Indication: Adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis |
Category: Cancer |
|
NKTR-214 (bempegaldesleukin) with Opdivo (nivolumab)
|
8/23/2019
|
|
Untreated melanoma patients with either metastatic disease or who are unable to undergo surgery
|
Cancer
|
|
Date of BT Designation Disclosure: 8/23/2019/2019
Approval Date: |
Indication: Untreated melanoma patients with either metastatic disease or who are unable to undergo surgery |
Category: Cancer |
|
Peginterferon Lambda
|
8/20/2019
|
|
Hepatitis delta virus (HDV) infection
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 8/20/2019/2019
Approval Date: |
Indication: Hepatitis delta virus (HDV) infection |
Category: Infectious Disease |
|
Calquence (acalabrutinib)
|
8/14/2019
|
11/21/2019
|
Adult patients with untreated chronic lymphocytic leukemia (CLL)
|
Cancer
|
|
Date of BT Designation Disclosure: 8/14/2019/2019
Approval Date: 2019 |
Indication: Adult patients with untreated chronic lymphocytic leukemia (CLL) |
Category: Cancer |
|
Calquence (acalabrutinib)
|
8/14/2019
|
11/21/2019
|
Adult patients with relapsed or refractory chronic lymphocytic leukemia
|
Cancer
|
|
Date of BT Designation Disclosure: 8/14/2019/2019
Approval Date: 2019 |
Indication: Adult patients with relapsed or refractory chronic lymphocytic leukemia |
Category: Cancer |
|
trilaciclib
|
8/07/2019
|
|
Patients with small cell lung cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 8/07/2019/2019
Approval Date: |
Indication: Patients with small cell lung cancer |
Category: Cancer |
|
DCR-PHXC
|
7/15/2019
|
|
Primary hyperoxaluria type 1 (caused by a mutation in the AGXT gene)
|
Other
|
|
Date of BT Designation Disclosure: 7/15/2019/2019
Approval Date: |
Indication: Primary hyperoxaluria type 1 (caused by a mutation in the AGXT gene) |
Category: Other |
|
Keytruda (pembrolizumab)
|
7/15/2019
|
|
Patients with hepatocellular carcinoma
|
Cancer
|
|
Date of BT Designation Disclosure: 7/15/2019/2019
Approval Date: |
Indication: Patients with hepatocellular carcinoma |
Category: Cancer |
|
Avexitide
|
6/17/2019
|
|
Post-bariatric hypoglycemia (PBH)
|
Other
|
|
Date of BT Designation Disclosure: 6/17/2019/2019
Approval Date: |
Indication: Post-bariatric hypoglycemia (PBH) |
Category: Other |
|
Aliqopa (copanlisib)
|
5/30/2019
|
|
Adults patients with relapsed marginal zone lymphoma (MZL) who have received at least 2 prior therapies
|
Cancer
|
|
Date of BT Designation Disclosure: 5/30/2019/2019
Approval Date: |
Indication: Adults patients with relapsed marginal zone lymphoma (MZL) who have received at least 2 prior therapies |
Category: Cancer |
|
LN-145
|
5/22/2019
|
|
Patients with recurrent, metastatic, or persistent cervical cancer who have progressed on or after chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 5/22/2019/2019
Approval Date: |
Indication: Patients with recurrent, metastatic, or persistent cervical cancer who have progressed on or after chemotherapy |
Category: Cancer |
|
Enhertu (fam-trastuzumab deruxtecan-nxki)
|
5/08/2019
|
12/20/2019
|
Adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
|
Cancer
|
|
Date of BT Designation Disclosure: 5/08/2019/2019
Approval Date: 2019 |
Indication: Adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting |
Category: Cancer |
|
SER-109
|
4/29/2019
|
|
Recurrent C. difficile infection
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/29/2019/2019
Approval Date: |
Indication: Recurrent C. difficile infection |
Category: Rare Inherited Disorders |
|
LJPC-0118
|
4/24/2019
|
|
Patients with severe malaria
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 4/24/2019/2019
Approval Date: |
Indication: Patients with severe malaria |
Category: Infectious Disease |
|
elafibranor
|
4/19/2019
|
|
Patients with primary biliary cholangitis (PBC)
|
Other
|
|
Date of BT Designation Disclosure: 4/19/2019/2019
Approval Date: |
Indication: Patients with primary biliary cholangitis (PBC) |
Category: Other |
|
Uplinza (inebilizumab-cdon)
|
4/18/2019
|
6/11/2020
|
Patients with neuromyelitis optica spectrum disorder (NMOSD)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/18/2019/2019
Approval Date: 2020 |
Indication: Patients with neuromyelitis optica spectrum disorder (NMOSD) |
Category: Rare Inherited Disorders |
|
PB2452
|
4/08/2019
|
|
Reversal agent for the antiplatelet drug ticagrelor
|
Other
|
|
Date of BT Designation Disclosure: 4/08/2019/2019
Approval Date: |
Indication: Reversal agent for the antiplatelet drug ticagrelor |
Category: Other |
|
Koselugo (Selumetinib)
|
4/01/2019
|
4/10/2020
|
Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/01/2019/2019
Approval Date: 2020 |
Indication: Treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) |
Category: Rare Inherited Disorders |
|
AXS-05
|
3/27/2019
|
|
Major Depressive Disorder (MDD)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 3/27/2019/2019
Approval Date: |
Indication: Major Depressive Disorder (MDD) |
Category: Rare Inherited Disorders |
|
Tibosovo (ivosidenib) and azacitidine
|
3/27/2019
|
|
newly diagnosed patients with IDH1-mutant acute myeloid leukemia (AML) ≥75 years old or are ineligible for intensive induction chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 3/27/2019/2019
Approval Date: |
Indication: newly diagnosed patients with IDH1-mutant acute myeloid leukemia (AML) ≥75 years old or are ineligible for intensive induction chemotherapy |
Category: Cancer |
|
Venclexta (venetoclax)
|
3/15/2019
|
5/15/2019
|
In combination with obinutuzumab for treatment of previously untreated patients with chronic lymphocytic leukemia (1L CLL) or small lymphocytic lymphoma (SLL)
|
Cancer
|
|
Date of BT Designation Disclosure: 3/15/2019/2019
Approval Date: 2019 |
Indication: In combination with obinutuzumab for treatment of previously untreated patients with chronic lymphocytic leukemia (1L CLL) or small lymphocytic lymphoma (SLL) |
Category: Cancer |
|
AXS-05
|
3/15/2019
|
|
Patients with major depressive disorder that is resistant to current treatments
|
Other
|
|
Date of BT Designation Disclosure: 3/15/2019/2019
Approval Date: |
Indication: Patients with major depressive disorder that is resistant to current treatments |
Category: Other |
|
Gavreto (Pralsentinib)
|
2/26/2019
|
9/04/2020
|
Patients with RET fusion-positive NSCLC that has progressed on platinum-based chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2/26/2019/2019
Approval Date: 2020 |
Indication: Patients with RET fusion-positive NSCLC that has progressed on platinum-based chemotherapy |
Category: Cancer |
|
AT-GAA (ATB200 + AT2221)
|
2/26/2019
|
|
Patients with late onset Pompe disease
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 2/26/2019/2019
Approval Date: |
Indication: Patients with late onset Pompe disease |
Category: Rare Inherited Disorders |
|
seladelpar
|
2/20/2019
|
|
Patients with early stage primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA)
|
Other
|
|
Date of BT Designation Disclosure: 2/20/2019/2019
Approval Date: |
Indication: Patients with early stage primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) |
Category: Other |
|
CP101
|
2/09/2019
|
|
Patients with recurrent Clostridium difficile infection
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 2/09/2019/2019
Approval Date: |
Indication: Patients with recurrent Clostridium difficile infection |
Category: Infectious Disease |
|
MEDI8897
|
2/06/2019
|
|
Prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV)
|
Other
|
|
Date of BT Designation Disclosure: 2/06/2019/2019
Approval Date: |
Indication: Prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) |
Category: Other |
|
Kadcyla (ado-trastuzumab emtansine)
|
2/05/2019
|
5/03/2019
|
Adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after neoadjuvant taxane and trastuzumab-based treatment
|
Cancer
|
|
Date of BT Designation Disclosure: 2/05/2019/2019
Approval Date: 2019 |
Indication: Adjuvant treatment of patients with HER2-positive early breast cancer who have residual disease after neoadjuvant taxane and trastuzumab-based treatment |
Category: Cancer |
|
umbralisib (TGR-1202)
|
1/28/2019
|
|
Adult patients with marginal zone lymphoma (MZL) who did not respond to at least one anti-CD20 therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 1/28/2019/2019
Approval Date: |
Indication: Adult patients with marginal zone lymphoma (MZL) who did not respond to at least one anti-CD20 therapy |
Category: Cancer |
|
V114
|
1/28/2019
|
|
Prevention of invasive pneumococcal disease
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 1/28/2019/2019
Approval Date: |
Indication: Prevention of invasive pneumococcal disease |
Category: Infectious Disease |
|
Brukinsa (zanubrutinib)
|
1/16/2019
|
11/14/2019
|
Patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 1/16/2019/2019
Approval Date: 2019 |
Indication: Patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
Category: Cancer |
|
Adakveo (crizanlizumab-tmca)
|
1/08/2019
|
11/15/2019
|
To reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/08/2019/2019
Approval Date: 2019 |
Indication: To reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease |
Category: Rare Inherited Disorders |
|
Braftovi (encorafenib)
|
2019
|
4/08/2020
|
In combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2019/2019
Approval Date: 2020 |
Indication: In combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy |
Category: Cancer |
|
TUKYSA (tucatinib)
|
2019
|
4/17/2020
|
In combination with trastuzumab and capecitabine, for the treatment of adult patients with advanced unresectable or metastatic HER2- positive breast cancer, including patients with brain metastases, who have received one or more prior antiHER2-based regim
|
Cancer
|
|
Date of BT Designation Disclosure: 2019/2019
Approval Date: 2020 |
Indication: In combination with trastuzumab and capecitabine, for the treatment of adult patients with advanced unresectable or metastatic HER2- positive breast cancer, including patients with brain metastases, who have received one or more prior antiHER2-based regim |
Category: Cancer |
|
Enspryng (satralizumab-mwge)
|
12/20/2018
|
8/14/2020
|
Subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 12/20/2018/2018
Approval Date: 2020 |
Indication: Subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). |
Category: Rare Inherited Disorders |
|
Olipudase Alfa
|
11/29/2018
|
|
Niemann-Pick disease Type B (NPB)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 11/29/2018/2018
Approval Date: |
Indication: Niemann-Pick disease Type B (NPB) |
Category: Rare Inherited Disorders |
|
lonafarnib
|
11/19/2018
|
11/20/2020
|
Patients with Hutchinson-Gilford progeria syndrome (HGPS_
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 11/19/2018/2018
Approval Date: 2020 |
Indication: Patients with Hutchinson-Gilford progeria syndrome (HGPS_ |
Category: Rare Inherited Disorders |
|
Promacta (eltrombopag)
|
11/16/2018
|
|
Low platelet counts in people exposed to radiation
|
Other
|
|
Date of BT Designation Disclosure: 11/16/2018/2018
Approval Date: |
Indication: Low platelet counts in people exposed to radiation |
Category: Other |
|
Emgality (galcanezumab)
|
11/15/2018
|
6/04/2019
|
Episodic cluster headache in adults
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 11/15/2018/2018
Approval Date: 2019 |
Indication: Episodic cluster headache in adults |
Category: Rare Inherited Disorders |
|
Adcetris (brentuximab vedotin)
|
11/15/2018
|
11/16/2018
|
Adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone
|
Cancer
|
|
Date of BT Designation Disclosure: 11/15/2018/2018
Approval Date: 2018 |
Indication: Adult patients with previously untreated systemic anaplastic large cell lymphoma or other CD30-expressing peripheral T-cell lymphomas (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone |
Category: Cancer |
|
NGX-101
|
11/13/2018
|
|
Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB) after initial stabilization with ketamine or other effective therapy
|
Other
|
|
Date of BT Designation Disclosure: 11/13/2018/2018
Approval Date: |
Indication: Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB) after initial stabilization with ketamine or other effective therapy |
Category: Other |
|
NRX-101
|
11/13/2018
|
|
Treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB)
|
Other
|
|
Date of BT Designation Disclosure: 11/13/2018/2018
Approval Date: |
Indication: Treatment of Severe Bipolar Depression with Acute Suicidal Ideation & Behavior (ASIB) |
Category: Other |
|
Jelmyto (mitomycin)
|
10/31/2018
|
4/15/2020
|
Treatment of adult patients with lowgrade upper tract urothelial cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 10/31/2018/2018
Approval Date: 2020 |
Indication: Treatment of adult patients with lowgrade upper tract urothelial cancer |
Category: Cancer |
|
Psilocybin therapy
|
10/23/2018
|
|
Treatment-resistant Depression
|
Other
|
|
Date of BT Designation Disclosure: 10/23/2018/2018
Approval Date: |
Indication: Treatment-resistant Depression |
Category: Other |
|
Myrcludex
|
10/23/2018
|
|
Chronic hepatitis delta (HDV) infection
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 10/23/2018/2018
Approval Date: |
Indication: Chronic hepatitis delta (HDV) infection |
Category: Infectious Disease |
|
Psilocybin formulation (Comp 360)
|
10/23/2018
|
|
Treatment-resistant depression
|
Other
|
|
Date of BT Designation Disclosure: 10/23/2018/2018
Approval Date: |
Indication: Treatment-resistant depression |
Category: Other |
|
KD025
|
10/17/2018
|
|
Patients with chronic graft-versus-host disease (cGVHD) after failure of two or more lines of systemic therapy
|
Other
|
|
Date of BT Designation Disclosure: 10/17/2018/2018
Approval Date: |
Indication: Patients with chronic graft-versus-host disease (cGVHD) after failure of two or more lines of systemic therapy |
Category: Other |
|
LOXO-292
|
10/16/2018
|
|
Patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment, and have no acceptable alternative treatment options
|
Cancer
|
|
Date of BT Designation Disclosure: 10/16/2018/2018
Approval Date: |
Indication: Patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment, and have no acceptable alternative treatment options |
Category: Cancer |
|
Retevmo (selpercatinib)
|
10/15/2018
|
5/08/2020
|
Patients with metastatic, RET-fusion-positive non-small-cell lung cancer (NSCLC) who require systemic therapy and progressed following anti PD-L1 therapy or platinum-based chemotherapy plus an anti-PD-1 therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/15/2018/2018
Approval Date: 2020 |
Indication: Patients with metastatic, RET-fusion-positive non-small-cell lung cancer (NSCLC) who require systemic therapy and progressed following anti PD-L1 therapy or platinum-based chemotherapy plus an anti-PD-1 therapy |
Category: Cancer |
|
Rubraca (rucaparib)
|
10/03/2018
|
|
BRCA1/BRCA2-mutated, metastatic, castration-resistant prostate cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 10/03/2018/2018
Approval Date: |
Indication: BRCA1/BRCA2-mutated, metastatic, castration-resistant prostate cancer |
Category: Cancer |
|
PF-06482077
|
9/20/2018
|
|
Prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 9/20/2018/2018
Approval Date: |
Indication: Prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older |
Category: Infectious Disease |
|
CA-008
|
9/11/2018
|
|
Patients needing long-lasting, non-opioid pain relief
|
Other
|
|
Date of BT Designation Disclosure: 9/11/2018/2018
Approval Date: |
Indication: Patients needing long-lasting, non-opioid pain relief |
Category: Other |
|
Tezepelumab
|
9/07/2018
|
|
Patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers
|
Other
|
|
Date of BT Designation Disclosure: 9/07/2018/2018
Approval Date: |
Indication: Patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers |
Category: Other |
|
PF-06651600
|
9/06/2018
|
|
Patients with alopecia areata
|
Other
|
|
Date of BT Designation Disclosure: 9/06/2018/2018
Approval Date: |
Indication: Patients with alopecia areata |
Category: Other |
|
LOXO-292
|
9/05/2018
|
|
Patients with metastatic RET-fusion-positive non-small cell lung cancer; patients with RET-mutant medullary thyroid cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 9/05/2018/2018
Approval Date: |
Indication: Patients with metastatic RET-fusion-positive non-small cell lung cancer; patients with RET-mutant medullary thyroid cancer |
Category: Cancer |
|
Danyelza (naxitamab-gqgk)
|
8/23/2018
|
11/25/2020
|
In combination with GM-CSF for patients with high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow
|
Cancer
|
|
Date of BT Designation Disclosure: 8/23/2018/2018
Approval Date: 2020 |
Indication: In combination with GM-CSF for patients with high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow |
Category: Cancer |
|
Xolair (omalizumab)
|
8/13/2018
|
9/28/2018
|
Prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies
|
Other
|
|
Date of BT Designation Disclosure: 8/13/2018/2018
Approval Date: 2018 |
Indication: Prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies |
Category: Other |
|
Braftovi (encorafenib) + Mektovi (binimetinib) + Erbitux (cetuximab)
|
8/07/2018
|
|
Patients with BRAF V600E-mutation metastatic colorectal caner following 1 or 2 prior lines of treatment in the metastatic setting
|
Cancer
|
|
Date of BT Designation Disclosure: 8/07/2018/2018
Approval Date: |
Indication: Patients with BRAF V600E-mutation metastatic colorectal caner following 1 or 2 prior lines of treatment in the metastatic setting |
Category: Cancer |
|
Quizartinib
|
8/01/2018
|
|
Adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML)
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2018/2018
Approval Date: |
Indication: Adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) |
Category: Cancer |
|
Keytruda (pembrolizumab)
|
8/01/2018
|
9/17/2019
|
In combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for surgery or radiation
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2018/2018
Approval Date: 2019 |
Indication: In combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for surgery or radiation |
Category: Cancer |
|
Lenvima (lenvatinib)
|
8/01/2018
|
9/17/2019
|
In combination with pembrolizumab for the treatment of patients with previously advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for surgery or radiation
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2018/2018
Approval Date: 2019 |
Indication: In combination with pembrolizumab for the treatment of patients with previously advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for surgery or radiation |
Category: Cancer |
|
Avastin (Bevacizumab)
|
7/18/2018
|
5/29/2020
|
In combination with atezolizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 7/18/2018/2018
Approval Date: 2020 |
Indication: In combination with atezolizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy |
Category: Cancer |
|
Tecentriq (atezolizumab)
|
7/18/2018
|
5/29/2020
|
In combination with bevacizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 7/18/2018/2018
Approval Date: 2020 |
Indication: In combination with bevacizumab, for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy |
Category: Cancer |
|
AMT-601
|
6/28/2018
|
|
Patients with severe and moderately severe hemophilia B
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 6/28/2018/2018
Approval Date: |
Indication: Patients with severe and moderately severe hemophilia B |
Category: Rare Inherited Disorders |
|
HTX-011
|
6/21/2018
|
|
Postoperative Pain Management
|
Other
|
|
Date of BT Designation Disclosure: 6/21/2018/2018
Approval Date: |
Indication: Postoperative Pain Management |
Category: Other |
|
Kisqali (ribociclib)
|
6/20/2018
|
7/18/2018
|
In combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 6/20/2018/2018
Approval Date: 2018 |
Indication: In combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy |
Category: Cancer |
|
Kisqali (ribociclib)
|
6/20/2018
|
7/18/2018
|
In combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 6/20/2018/2018
Approval Date: 2018 |
Indication: In combination with an aromatase inhibitor for pre/perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy |
Category: Cancer |
|
Elzonris (tagraxofusp)
|
6/15/2018
|
12/21/2018
|
Adults and children aged 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN)
|
Cancer
|
|
Date of BT Designation Disclosure: 6/15/2018/2018
Approval Date: 2018 |
Indication: Adults and children aged 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN) |
Category: Cancer |
|
Xalkori (crizotinib)
|
5/29/2018
|
1/15/2021
|
Patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive
|
Cancer
|
|
Date of BT Designation Disclosure: 5/29/2018/2018
Approval Date: 2021 |
Indication: Patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive |
Category: Cancer |
|
Xalkori (crizotinib)
|
5/29/2018
|
|
Patients with metastatic non-small cell lung cancer with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 5/29/2018/2018
Approval Date: |
Indication: Patients with metastatic non-small cell lung cancer with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy |
Category: Cancer |
|
Vyndaquel (tafamidis meglumine)
|
5/24/2018
|
5/03/2019
|
Patients with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular related hospitalization
|
Other
|
|
Date of BT Designation Disclosure: 5/24/2018/2018
Approval Date: 2019 |
Indication: Patients with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular related hospitalization |
Category: Other |
|
Tafamidis
|
5/23/2018
|
|
Transthyretin Cardiomyopathy (ATTR-ACT)
|
Cardiovascular
|
|
Date of BT Designation Disclosure: 5/23/2018/2018
Approval Date: |
Indication: Transthyretin Cardiomyopathy (ATTR-ACT) |
Category: Cardiovascular |
|
Lenti-D
|
5/23/2018
|
|
Cerebral adrenoleukodystrophy
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 5/23/2018/2018
Approval Date: |
Indication: Cerebral adrenoleukodystrophy |
Category: Rare Inherited Disorders |
|
Pitolisant
|
5/21/2018
|
|
Excessive daytime sleepiness and cataplexy in patients with narcolepsy
|
Other
|
|
Date of BT Designation Disclosure: 5/21/2018/2018
Approval Date: |
Indication: Excessive daytime sleepiness and cataplexy in patients with narcolepsy |
Category: Other |
|
Trikafta (elexacaftor/ivacaftor/tezacaftor)
|
5/01/2018
|
10/21/2019
|
Patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 5/01/2018/2018
Approval Date: 2019 |
Indication: Patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene |
Category: Rare Inherited Disorders |
|
OMS721
|
4/26/2018
|
|
Patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patents who have persistent TMA despite modification of immunosupressive therapy
|
Other
|
|
Date of BT Designation Disclosure: 4/26/2018/2018
Approval Date: |
Indication: Patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patents who have persistent TMA despite modification of immunosupressive therapy |
Category: Other |
|
Trumenba (Meningococcal Group B Vaccine)
|
4/23/2018
|
|
Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 1 through 9 years of age
|
|
|
Date of BT Designation Disclosure: 4/23/2018/2018
Approval Date: |
Indication: Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 1 through 9 years of age |
Category: |
|
Hemlibra (emicizumab-kxwh)
|
4/17/2018
|
10/04/2018
|
Patients with hemophilia A without factor VIII inhibitors
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/17/2018/2018
Approval Date: 2018 |
Indication: Patients with hemophilia A without factor VIII inhibitors |
Category: Rare Inherited Disorders |
|
Ketamine
|
4/16/2018
|
|
Patients with depression
|
Other
|
|
Date of BT Designation Disclosure: 4/16/2018/2018
Approval Date: |
Indication: Patients with depression |
Category: Other |
|
ALIS (amikacin liposome inhalation suspension)
|
3/29/2018
|
|
Adult patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex
|
Other
|
|
Date of BT Designation Disclosure: 3/29/2018/2018
Approval Date: |
Indication: Adult patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex |
Category: Other |
|
Pedmark (sodium thiosulfate)
|
3/27/2018
|
|
Prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB)
|
Other
|
|
Date of BT Designation Disclosure: 3/27/2018/2018
Approval Date: |
Indication: Prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB) |
Category: Other |
|
enfortumab vedotin
|
3/26/2018
|
|
Patients with locally advanced or metastatic urothelial carcinoma
|
Cancer
|
|
Date of BT Designation Disclosure: 3/26/2018/2018
Approval Date: |
Indication: Patients with locally advanced or metastatic urothelial carcinoma |
Category: Cancer |
|
Padcev (enfortumab vedotin-ejfv)
|
3/26/2018
|
12/18/2019
|
Patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting
|
Cancer
|
|
Date of BT Designation Disclosure: 3/26/2018/2018
Approval Date: 2019 |
Indication: Patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting |
Category: Cancer |
|
PTI-428
|
3/16/2018
|
|
Cystic Fibrosis for patients with two copies of the F508del mutation — one from their mother and one from their father — who are receiving Vertex’s Orkambi (lumacaftor/ivacaftor)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 3/16/2018/2018
Approval Date: |
Indication: Cystic Fibrosis for patients with two copies of the F508del mutation — one from their mother and one from their father — who are receiving Vertex’s Orkambi (lumacaftor/ivacaftor) |
Category: Rare Inherited Disorders |
|
Balversa (erdafitinib)
|
3/15/2018
|
4/12/2019
|
Adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during at least on line of platinum-containing chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 3/15/2018/2018
Approval Date: 2019 |
Indication: Adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and progressed during at least on line of platinum-containing chemotherapy |
Category: Cancer |
|
Oxlumo (lumasiran)
|
3/12/2018
|
11/23/2020
|
Primary Hyperoxaluria Type 1 (PH1)
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 3/12/2018/2018
Approval Date: 2020 |
Indication: Primary Hyperoxaluria Type 1 (PH1) |
Category: Infectious Disease |
|
Orkambi (lumacaftor/ivacaftor)
|
3/12/2018
|
8/07/2018
|
Treatment of cystic fibrosis (CF) in patients 2 years and older, homozygous for the F508del-CFTR mutation in the CFTR gene
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 3/12/2018/2018
Approval Date: 2018 |
Indication: Treatment of cystic fibrosis (CF) in patients 2 years and older, homozygous for the F508del-CFTR mutation in the CFTR gene |
Category: Rare Inherited Disorders |
|
BIVV009
|
3/06/2018
|
|
Patients with cold agglutinin disease (CAgD)
|
Other
|
|
Date of BT Designation Disclosure: 3/06/2018/2018
Approval Date: |
Indication: Patients with cold agglutinin disease (CAgD) |
Category: Other |
|
GC4419
|
2/28/2018
|
|
Reduction of the duration, severity, and incidence of severe oral mucositis induced by radiation therapy
|
Other
|
|
Date of BT Designation Disclosure: 2/28/2018/2018
Approval Date: |
Indication: Reduction of the duration, severity, and incidence of severe oral mucositis induced by radiation therapy |
Category: Other |
|
Opdivo (nivolumab)
|
2/16/2018
|
4/16/2018
|
In combination with ipilimumab, for treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC
|
Cancer
|
|
Date of BT Designation Disclosure: 2/16/2018/2018
Approval Date: 2018 |
Indication: In combination with ipilimumab, for treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC |
Category: Cancer |
|
Yervoy (ipilimumab)
|
2/16/2018
|
4/16/2018
|
In combination with nivolumab, for treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 2/16/2018/2018
Approval Date: 2018 |
Indication: In combination with nivolumab, for treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC) |
Category: Cancer |
|
SPK-8011
|
2/15/2018
|
|
Patients with hemophilia A.
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 2/15/2018/2018
Approval Date: |
Indication: Patients with hemophilia A. |
Category: Rare Inherited Disorders |
|
Abrocitinib
|
2/15/2018
|
|
Patients with atopic dermatitis
|
Other
|
|
Date of BT Designation Disclosure: 2/15/2018/2018
Approval Date: |
Indication: Patients with atopic dermatitis |
Category: Other |
|
PF-04965842
|
2/14/2018
|
|
Patients with moderate-to-severe atopic dermatitis (AD)
|
Other
|
|
Date of BT Designation Disclosure: 2/14/2018/2018
Approval Date: |
Indication: Patients with moderate-to-severe atopic dermatitis (AD) |
Category: Other |
|
Opdivo (nivolumab)
|
2/10/2018
|
6/10/2018
|
Patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
|
Cancer
|
|
Date of BT Designation Disclosure: 2/10/2018/2018
Approval Date: 2018 |
Indication: Patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan |
Category: Cancer |
|
Yervoy (ipilimumab)
|
2/10/2018
|
7/10/2018
|
Patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan
|
Cancer
|
|
Date of BT Designation Disclosure: 2/10/2018/2018
Approval Date: 2018 |
Indication: Patients 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan |
Category: Cancer |
|
SAGE-217
|
2/07/2018
|
|
Patients with major depressive disorder (MDD)
|
Other
|
|
Date of BT Designation Disclosure: 2/07/2018/2018
Approval Date: |
Indication: Patients with major depressive disorder (MDD) |
Category: Other |
|
ZX008 (fenfluramine)
|
2/06/2018
|
|
Patients who have seizures associated with Dravet syndrome
|
Other
|
|
Date of BT Designation Disclosure: 2/06/2018/2018
Approval Date: |
Indication: Patients who have seizures associated with Dravet syndrome |
Category: Other |
|
Onpattro (patisiran)
|
2/02/2018
|
8/10/2018
|
Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 2/02/2018/2018
Approval Date: 2018 |
Indication: Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults |
Category: Rare Inherited Disorders |
|
Balovaptan
|
1/29/2018
|
|
Autism spectrum disorder (ASD)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/29/2018/2018
Approval Date: |
Indication: Autism spectrum disorder (ASD) |
Category: Rare Inherited Disorders |
|
Balovaptan (RG7314)
|
1/28/2018
|
|
A vasopressin 1a (V1a) receptor antagonist for patients with autism spectrum disorder (ASD)
|
Other
|
|
Date of BT Designation Disclosure: 1/28/2018/2018
Approval Date: |
Indication: A vasopressin 1a (V1a) receptor antagonist for patients with autism spectrum disorder (ASD) |
Category: Other |
|
Kisquali Femara Co-Pack (letrozole and ribociclib)
|
1/10/2018
|
2/13/2019
|
Treatment of pre/perimenopausal women with HR-positive, HER2- negative advanced or metastatic breast cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 1/10/2018/2018
Approval Date: 2019 |
Indication: Treatment of pre/perimenopausal women with HR-positive, HER2- negative advanced or metastatic breast cancer |
Category: Cancer |
|
Upadacitinib (ABT-494)
|
1/09/2018
|
|
Adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy
|
Other
|
|
Date of BT Designation Disclosure: 1/09/2018/2018
Approval Date: |
Indication: Adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy |
Category: Other |
|
Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab)
|
1/09/2018
|
|
Advanced and/or metastatic renal cell carcinoma (RCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 1/09/2018/2018
Approval Date: |
Indication: Advanced and/or metastatic renal cell carcinoma (RCC) |
Category: Cancer |
|
Oxbryta (voxelotor)
|
1/09/2018
|
11/25/2019
|
Sickle cell disease (SCD) in patients 12 years and older
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/09/2018/2018
Approval Date: 2019 |
Indication: Sickle cell disease (SCD) in patients 12 years and older |
Category: Rare Inherited Disorders |
|
Maribavir (SHP620)
|
1/08/2018
|
|
Cytomegalovirus (CMV) infection in transplant patients.
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 1/08/2018/2018
Approval Date: |
Indication: Cytomegalovirus (CMV) infection in transplant patients. |
Category: Infectious Disease |
|
Promacta (eltrombopag)
|
1/04/2018
|
11/16/2018
|
First-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/04/2018/2018
Approval Date: 2018 |
Indication: First-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST) |
Category: Rare Inherited Disorders |
|
Gamifant (emapalumab-Izsg)
|
2018
|
11/20/2018
|
Adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 2018/2018
Approval Date: 2018 |
Indication: Adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy |
Category: Rare Inherited Disorders |
|
Venclexta (venetoclax)
|
2018
|
6/08/2018
|
Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2018/2018
Approval Date: 2018 |
Indication: Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy |
Category: Cancer |
|
Bavencio (avelumab)
|
12/22/2017
|
5/14/2019
|
In combination with Inlyta (axitinib) for first-line treatment of patients with advanced renal cell carcinoma (RCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 12/22/2017/2017
Approval Date: 2019 |
Indication: In combination with Inlyta (axitinib) for first-line treatment of patients with advanced renal cell carcinoma (RCC) |
Category: Cancer |
|
Avelumab in combination with Inlyta (axitinib)
|
12/21/2017
|
|
Treatment-naïve patients with advanced renal cell carcinoma (RCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 12/21/2017/2017
Approval Date: |
Indication: Treatment-naïve patients with advanced renal cell carcinoma (RCC) |
Category: Cancer |
|
Gilenya (fingolimod)
|
12/18/2017
|
5/11/2018
|
Patients with relapsing multiple sclerosis (MS) to include pediatric patients 10 years of age and above
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 12/18/2017/2017
Approval Date: 2018 |
Indication: Patients with relapsing multiple sclerosis (MS) to include pediatric patients 10 years of age and above |
Category: Rare Inherited Disorders |
|
Polivy (polatuzumab vedotin-piiq)
|
12/10/2017
|
6/10/2019
|
In combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies
|
Cancer
|
|
Date of BT Designation Disclosure: 12/10/2017/2017
Approval Date: 2019 |
Indication: In combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies |
Category: Cancer |
|
Keytruda (pembrolizumab)
|
12/10/2017
|
4/19/2019
|
In combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 12/10/2017/2017
Approval Date: 2019 |
Indication: In combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC) |
Category: Cancer |
|
Oxervate (cenegermin-bkbj ophthalmic solution)
|
11/30/2017
|
8/22/2018
|
Patients with neurotrophic keratitis (NK)
|
Other
|
|
Date of BT Designation Disclosure: 11/30/2017/2017
Approval Date: 2018 |
Indication: Patients with neurotrophic keratitis (NK) |
Category: Other |
|
Idecabtagene vicleucel
|
11/15/2017
|
|
Adult patients with relapsed or refractory multiple myeloma
|
Cancer
|
|
Date of BT Designation Disclosure: 11/15/2017/2017
Approval Date: |
Indication: Adult patients with relapsed or refractory multiple myeloma |
Category: Cancer |
|
bb2121
|
11/04/2017
|
|
Patients with relapsed or refractory multiple myeloma
|
Cancer
|
|
Date of BT Designation Disclosure: 11/04/2017/2017
Approval Date: |
Indication: Patients with relapsed or refractory multiple myeloma |
Category: Cancer |
|
Blenrep (BELANTAMAB MAFODOTIN-BLMF)
|
11/02/2017
|
8/05/2020
|
Treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent
|
Cancer
|
|
Date of BT Designation Disclosure: 11/02/2017/2017
Approval Date: 2020 |
Indication: Treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent |
Category: Cancer |
|
Valoctocogene Roxaparvovec
|
10/26/2017
|
|
Hemophilia A
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 10/26/2017/2017
Approval Date: |
Indication: Hemophilia A |
Category: Rare Inherited Disorders |
|
Poteligeo (mogamulizumab-kpkc)
|
10/25/2017
|
8/08/2018
|
Adult patients Sézary syndrome (SS) after at least one prior systemic therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/25/2017/2017
Approval Date: 2018 |
Indication: Adult patients Sézary syndrome (SS) after at least one prior systemic therapy |
Category: Cancer |
|
Venclexta (venetoclax)
|
10/25/2017
|
11/21/2018
|
In combination with azacitidine, decitabine, or low-dose cytarabine for adults aged 75 and older with treatment-naive acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/25/2017/2017
Approval Date: 2018 |
Indication: In combination with azacitidine, decitabine, or low-dose cytarabine for adults aged 75 and older with treatment-naive acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy |
Category: Cancer |
|
Monjuvi
|
10/23/2017
|
7/31/2020
|
Relapsed/Refractory DLBCL who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation
|
Cancer
|
|
Date of BT Designation Disclosure: 10/23/2017/2017
Approval Date: 2020 |
Indication: Relapsed/Refractory DLBCL who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation |
Category: Cancer |
|
Tafinlar (dabrafenib)
|
10/23/2017
|
4/30/2018
|
In combination with trametinib for the adjuvant treatment of patients with stage III melanoma with a BRAF V600E or V600K mutation, as detected by and FDA-approved test, and involvement of lymph node(s), following complete resection
|
Cancer
|
|
Date of BT Designation Disclosure: 10/23/2017/2017
Approval Date: 2018 |
Indication: In combination with trametinib for the adjuvant treatment of patients with stage III melanoma with a BRAF V600E or V600K mutation, as detected by and FDA-approved test, and involvement of lymph node(s), following complete resection |
Category: Cancer |
|
Mekinist (trametinib)
|
10/23/2017
|
4/30/2018
|
In combination with dabrafenib for the adjuvant treatment of patients with stage III melanoma with a BRAF V600E or V600K mutation, as detected by and FDA-approved test, and involvement of lymph node(s), following complete resection
|
Cancer
|
|
Date of BT Designation Disclosure: 10/23/2017/2017
Approval Date: 2018 |
Indication: In combination with dabrafenib for the adjuvant treatment of patients with stage III melanoma with a BRAF V600E or V600K mutation, as detected by and FDA-approved test, and involvement of lymph node(s), following complete resection |
Category: Cancer |
|
Mekinist (trametinib)
|
10/23/2017
|
5/04/2018
|
In combination with dabrafenib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
|
Cancer
|
|
Date of BT Designation Disclosure: 10/23/2017/2017
Approval Date: 2018 |
Indication: In combination with dabrafenib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options |
Category: Cancer |
|
Tafinlar (dabrafenib)
|
10/23/2017
|
5/04/2018
|
In combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
|
Cancer
|
|
Date of BT Designation Disclosure: 10/23/2017/2017
Approval Date: 2018 |
Indication: In combination with trametinib for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options |
Category: Cancer |
|
Opdivo (nivolumab)
|
10/17/2017
|
12/20/2017
|
Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
|
Cancer
|
|
Date of BT Designation Disclosure: 10/17/2017/2017
Approval Date: 2017 |
Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection |
Category: Cancer |
|
Adcetris (brentuximab vedotin)
|
10/15/2017
|
3/20/2018
|
Treatment for adult patients with previously untreated Stage III or IV classical Hodgkin Lymphoma, in combination with chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/15/2017/2017
Approval Date: 2018 |
Indication: Treatment for adult patients with previously untreated Stage III or IV classical Hodgkin Lymphoma, in combination with chemotherapy |
Category: Cancer |
|
DAS181
|
10/10/2017
|
|
Treatment of lower respiratory tract parainfluenza virus (PIV) infection in immunocompromised patients
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 10/10/2017/2017
Approval Date: |
Indication: Treatment of lower respiratory tract parainfluenza virus (PIV) infection in immunocompromised patients |
Category: Infectious Disease |
|
Tagrisso (osimertinib)
|
10/09/2017
|
4/18/2018
|
First-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions of L858R substitution mutations, as detected by an FDA approved test
|
Cancer
|
|
Date of BT Designation Disclosure: 10/09/2017/2017
Approval Date: 2018 |
Indication: First-line treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions of L858R substitution mutations, as detected by an FDA approved test |
Category: Cancer |
|
Adcetris (brentuximab vedotin)
|
10/02/2017
|
11/09/2017
|
Patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/02/2017/2017
Approval Date: 2017 |
Indication: Patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy |
Category: Cancer |
|
Libtayo (cemiplimab-rwlc)
|
9/08/2017
|
9/28/2018
|
Patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation
|
Cancer
|
|
Date of BT Designation Disclosure: 9/08/2017/2017
Approval Date: 2018 |
Indication: Patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation |
Category: Cancer |
|
EB-101
|
8/30/2017
|
|
Recessive Dystrophic Epidermolysis Bullosa (RDEB)
|
Other
|
|
Date of BT Designation Disclosure: 8/30/2017/2017
Approval Date: |
Indication: Recessive Dystrophic Epidermolysis Bullosa (RDEB) |
Category: Other |
|
Trastuzumab Deruxtecan (DS-8201)
|
8/29/2017
|
|
HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla)
|
Cancer
|
|
Date of BT Designation Disclosure: 8/29/2017/2017
Approval Date: |
Indication: HER2-positive, locally advanced, or metastatic breast cancer who have been treated with trastuzumab (Herceptin) and pertuzumab (Perjeta) and have disease progression after ado-trastuzumab emtansine (T-DM1; Kadcyla) |
Category: Cancer |
|
Methylenedioxymethamphetamine (MDMA)
|
8/28/2017
|
|
PTSD
|
Other
|
|
Date of BT Designation Disclosure: 8/28/2017/2017
Approval Date: |
Indication: PTSD |
Category: Other |
|
Poteligeo (mogamulizumab-kpkc)
|
8/25/2017
|
8/08/2018
|
Adult patients with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome after at least one prior systemic therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/25/2017/2017
Approval Date: 2018 |
Indication: Adult patients with relapsed or refractory mycosis fungoides (MF) or Sezary syndrome after at least one prior systemic therapy |
Category: Cancer |
|
Zelboraf (vemurafenib)
|
8/07/2017
|
11/06/2017
|
Patients with Erdheim-Chester disease (ECD) with a BRAF V600 mutation
|
Other
|
|
Date of BT Designation Disclosure: 8/07/2017/2017
Approval Date: 2017 |
Indication: Patients with Erdheim-Chester disease (ECD) with a BRAF V600 mutation |
Category: Other |
|
Venetoclax
|
8/01/2017
|
|
Elderly patients with previously untreated Acute Myeloid Leukemia (AML) who are ineligible for intensive chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2017/2017
Approval Date: |
Indication: Elderly patients with previously untreated Acute Myeloid Leukemia (AML) who are ineligible for intensive chemotherapy |
Category: Cancer |
|
Acalabrutinib
|
8/01/2017
|
|
Mantle cell lymphoma for patients who have received at least one prior line of therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2017/2017
Approval Date: |
Indication: Mantle cell lymphoma for patients who have received at least one prior line of therapy |
Category: Cancer |
|
Calquence (acalabrutinib)
|
8/01/2017
|
10/31/2017
|
Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2017/2017
Approval Date: 2017 |
Indication: Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
Category: Cancer |
|
Imfinzi (durvalumab)
|
7/31/2017
|
2/16/2018
|
Patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 7/31/2017/2017
Approval Date: 2018 |
Indication: Patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy |
Category: Cancer |
|
Keytruda (pembrolizumab)
|
7/01/2017
|
12/19/2018
|
Adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)
|
Cancer
|
|
Date of BT Designation Disclosure: 7/01/2017/2017
Approval Date: 2018 |
Indication: Adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) |
Category: Cancer |
|
Korsuva (difelikefalin)
|
6/22/2017
|
|
Chronic kidney disease, associated pruritius in hemodialysis patients
|
Other
|
|
Date of BT Designation Disclosure: 6/22/2017/2017
Approval Date: |
Indication: Chronic kidney disease, associated pruritius in hemodialysis patients |
Category: Other |
|
OMS721
|
6/13/2017
|
|
Immunoglobulin A (IgA) nephropathy
|
Other
|
|
Date of BT Designation Disclosure: 6/13/2017/2017
Approval Date: |
Indication: Immunoglobulin A (IgA) nephropathy |
Category: Other |
|
Burtomab
|
6/07/2017
|
|
Pediatric patients with relapsed or refractory neuroblastoma with central nervous system or leptomeningeal metastasis
|
Cancer
|
|
Date of BT Designation Disclosure: 6/07/2017/2017
Approval Date: |
Indication: Pediatric patients with relapsed or refractory neuroblastoma with central nervous system or leptomeningeal metastasis |
Category: Cancer |
|
Ayvakit (avapritinib)
|
6/01/2017
|
1/09/2020
|
Patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation
|
Cancer
|
|
Date of BT Designation Disclosure: 6/01/2017/2017
Approval Date: 2020 |
Indication: Patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation |
Category: Cancer |
|
Givlaari (givosiran)
|
5/30/2017
|
11/20/2019
|
Adult patients with acute hepatic porphyria (AHP)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 5/30/2017/2017
Approval Date: 2019 |
Indication: Adult patients with acute hepatic porphyria (AHP) |
Category: Rare Inherited Disorders |
|
Zemdri (plazomicin)
|
5/23/2017
|
|
Antibacterials addressing multi-drug resistant (MDR) gram-negative infections
|
Other
|
|
Date of BT Designation Disclosure: 5/23/2017/2017
Approval Date: |
Indication: Antibacterials addressing multi-drug resistant (MDR) gram-negative infections |
Category: Other |
|
GMI-1271
|
5/17/2017
|
|
Adult Relapsed/Refractory Acute Myeloid Leukemia
|
Cancer
|
|
Date of BT Designation Disclosure: 5/17/2017/2017
Approval Date: |
Indication: Adult Relapsed/Refractory Acute Myeloid Leukemia |
Category: Cancer |
|
Rozlytrek (entrectinib)
|
5/15/2017
|
8/15/2019
|
Adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic, and have progressed following treatment or have no alternative treatment option
|
Cancer
|
|
Date of BT Designation Disclosure: 5/15/2017/2017
Approval Date: 2019 |
Indication: Adult and pediatric patients 12 years of age and older with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic, and have progressed following treatment or have no alternative treatment option |
Category: Cancer |
|
Ribaxamase (SYN-004)
|
5/11/2017
|
|
prevention of Clostridium difficile infection
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 5/11/2017/2017
Approval Date: |
Indication: prevention of Clostridium difficile infection |
Category: Infectious Disease |
|
Vonapanitase
|
5/10/2017
|
|
Increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis
|
Other
|
|
Date of BT Designation Disclosure: 5/10/2017/2017
Approval Date: |
Indication: Increasing arteriovenous fistula secondary patency (i.e., survival of the fistula without abandonment) and use for hemodialysis in patients on or expected to initiate hemodialysis |
Category: Other |
|
Lorbrena (lorlatinib)
|
4/27/2017
|
11/02/2018
|
Patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or alectinib or ceritinib
|
Cancer
|
|
Date of BT Designation Disclosure: 4/27/2017/2017
Approval Date: 2018 |
Indication: Patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or alectinib or ceritinib |
Category: Cancer |
|
Kymriah (tisagenlecleucel)
|
4/18/2017
|
|
Patients with large B-cell lymphoma
|
Cancer
|
|
Date of BT Designation Disclosure: 4/18/2017/2017
Approval Date: |
Indication: Patients with large B-cell lymphoma |
Category: Cancer |
|
Kymriah (CTL019)
|
4/18/2017
|
|
Adult patients with relapsed and refractory diffuse large B-cell lymphoma, who have failed two or more prior therapies
|
Cancer
|
|
Date of BT Designation Disclosure: 4/18/2017/2017
Approval Date: |
Indication: Adult patients with relapsed and refractory diffuse large B-cell lymphoma, who have failed two or more prior therapies |
Category: Cancer |
|
RVT-802
|
4/17/2017
|
|
Complete DiGeorge Syndrome (cDGS)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/17/2017/2017
Approval Date: |
Indication: Complete DiGeorge Syndrome (cDGS) |
Category: Rare Inherited Disorders |
|
Evinacumab
|
4/07/2017
|
|
Homozygous familial hypercholesterolemia (HOFH)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 4/07/2017/2017
Approval Date: |
Indication: Homozygous familial hypercholesterolemia (HOFH) |
Category: Rare Inherited Disorders |
|
Rituximab (Rituxan)
|
3/24/2017
|
6/07/2018
|
Patients with moderate to severe pemphigus vulgaris (PV)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 3/24/2017/2017
Approval Date: 2018 |
Indication: Patients with moderate to severe pemphigus vulgaris (PV) |
Category: Rare Inherited Disorders |
|
Prevymis (letermovir)
|
2/27/2017
|
11/08/2017
|
Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 2/27/2017/2017
Approval Date: 2017 |
Indication: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) |
Category: Infectious Disease |
|
Toca 511 & Toca FC
|
2/23/2017
|
|
Recurrent high grade glioma
|
Cancer
|
|
Date of BT Designation Disclosure: 2/23/2017/2017
Approval Date: |
Indication: Recurrent high grade glioma |
Category: Cancer |
|
AMT-060
|
1/20/2017
|
|
Hemophilia B
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 1/20/2017/2017
Approval Date: |
Indication: Hemophilia B |
Category: Rare Inherited Disorders |
|
Nuplazid (pimavanserin)
|
2017
|
|
Patients with dementia-related psychosis (DRP)
|
Other
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: |
Indication: Patients with dementia-related psychosis (DRP) |
Category: Other |
|
Keytruda (pembrolizumab)
|
2017
|
6/13/2018
|
Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2018 |
Indication: Adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy |
Category: Cancer |
|
Ibrance (palbociclib)
|
2017
|
4/04/2019
|
In combination with an aromatase inhibitor, or in combination with fulvestrant, for treatment of male patients with advanced or metastatic breast cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2019 |
Indication: In combination with an aromatase inhibitor, or in combination with fulvestrant, for treatment of male patients with advanced or metastatic breast cancer |
Category: Cancer |
|
Keytruda (pembrolizumab)
|
2017
|
5/18/2017
|
Patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neo- or neo-adjuvant treatment with platinum-containing chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neo- or neo-adjuvant treatment with platinum-containing chemotherapy |
Category: Cancer |
|
Keytruda (pembrolizumab)
|
2017
|
5/23/2017
|
Adult and pediatric patients with unresectable or metastatic MSI-H or mismatch repair deficient solid tumors that have progressed following prior treatment or metastatic, MSI-H or mistmatch repair colorectal cancer that has progressed following treatment
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Adult and pediatric patients with unresectable or metastatic MSI-H or mismatch repair deficient solid tumors that have progressed following prior treatment or metastatic, MSI-H or mistmatch repair colorectal cancer that has progressed following treatment |
Category: Cancer |
|
Zykadia (ceritinib)
|
2017
|
5/26/2017
|
Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA approved test
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA approved test |
Category: Cancer |
|
Ibrance (palbociclib)
|
2017
|
3/31/2017
|
Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor as initial endocrine-based therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor as initial endocrine-based therapy |
Category: Cancer |
|
Mekinist (trametinib)
|
2017
|
6/22/2017
|
Patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by and FDA-approved test
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by and FDA-approved test |
Category: Cancer |
|
Besponsa (inotuzumab ozogamicin)
|
2017
|
8/17/2017
|
Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
|
Cancer
|
|
Date of BT Designation Disclosure: 2017/2017
Approval Date: 2017 |
Indication: Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) |
Category: Cancer |
|
Liso-cel (Lisocabtagene maraleucel)
|
12/20/2016
|
|
Relapsed/refractory (r/r) aggressive large B-cell NHL, including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), Primary Mediastinal B-cell Lymphoma (PMBCL) or Grade 3B Follicular Lymphoma
|
Cancer
|
|
Date of BT Designation Disclosure: 12/20/2016/2016
Approval Date: |
Indication: Relapsed/refractory (r/r) aggressive large B-cell NHL, including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), Primary Mediastinal B-cell Lymphoma (PMBCL) or Grade 3B Follicular Lymphoma |
Category: Cancer |
|
Tonmya (TNX-102 SL)
|
12/19/2016
|
|
PTSD
|
Other
|
|
Date of BT Designation Disclosure: 12/19/2016/2016
Approval Date: |
Indication: PTSD |
Category: Other |
|
Neridronic acid
|
12/16/2016
|
|
Complex regional pain syndrome (CRPS)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 12/16/2016/2016
Approval Date: |
Indication: Complex regional pain syndrome (CRPS) |
Category: Rare Inherited Disorders |
|
Advantage Arrest™ Silver Diamine Fluoride 38%
|
11/03/2016
|
|
Arrest of tooth decay in children and adults
|
Other
|
|
Date of BT Designation Disclosure: 11/03/2016/2016
Approval Date: |
Indication: Arrest of tooth decay in children and adults |
Category: Other |
|
Zejula (niraparib)
|
10/14/2016
|
3/27/2017
|
Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 10/14/2016/2016
Approval Date: 2017 |
Indication: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy |
Category: Cancer |
|
omidubicel
|
10/11/2016
|
|
Patients with high-risk blood cancers who do not have a suitable matched donor
|
Cancer
|
|
Date of BT Designation Disclosure: 10/11/2016/2016
Approval Date: |
Indication: Patients with high-risk blood cancers who do not have a suitable matched donor |
Category: Cancer |
|
Omidubicel (formerly known as NiCord®)
|
10/11/2016
|
|
Treatment opportunity for patients who need an allogeneic bone marrow transplant. Cellular therapy in Phase 3 development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution
|
Cancer
|
|
Date of BT Designation Disclosure: 10/11/2016/2016
Approval Date: |
Indication: Treatment opportunity for patients who need an allogeneic bone marrow transplant. Cellular therapy in Phase 3 development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution |
Category: Cancer |
|
Elbit Imaging
|
10/10/2016
|
|
Nicord
|
Cancer
|
|
Date of BT Designation Disclosure: 10/10/2016/2016
Approval Date: |
Indication: Nicord |
Category: Cancer |
|
Actemra (tocilizumab)
|
10/05/2016
|
5/22/2017
|
Adult patients with giant cell arteritis (GCA)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 10/05/2016/2016
Approval Date: 2017 |
Indication: Adult patients with giant cell arteritis (GCA) |
Category: Rare Inherited Disorders |
|
Alecensa (alectinib)
|
10/04/2016
|
|
Adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor
|
Cancer
|
|
Date of BT Designation Disclosure: 10/04/2016/2016
Approval Date: |
Indication: Adult patients with advanced ALK-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor |
Category: Cancer |
|
Dupixent (Dupilumab)
|
10/01/2016
|
3/11/2019
|
Patients 12 to less than 18 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
|
Other
|
|
Date of BT Designation Disclosure: 10/01/2016/2016
Approval Date: 2019 |
Indication: Patients 12 to less than 18 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable |
Category: Other |
|
ABT-530
|
9/30/2016
|
|
genotype 1 HCV patients who have failed to respond to a previous therapy of direct acting antivirals (or DAAs)
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 9/30/2016/2016
Approval Date: |
Indication: genotype 1 HCV patients who have failed to respond to a previous therapy of direct acting antivirals (or DAAs) |
Category: Infectious Disease |
|
Mavyret (glecaprevir & pibrentasvir)
|
9/30/2016
|
8/03/2017
|
Patients with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; and also for patients with HCV GT1 infection previously treated w/ HCV NS5A or NS3/4A inhibitor but not both
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 9/30/2016/2016
Approval Date: 2017 |
Indication: Patients with chronic hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; and also for patients with HCV GT1 infection previously treated w/ HCV NS5A or NS3/4A inhibitor but not both |
Category: Infectious Disease |
|
Zulresso (Brexanolone)
|
9/06/2016
|
3/19/2019
|
Postpartum depression (PPD)
|
Other
|
|
Date of BT Designation Disclosure: 9/06/2016/2016
Approval Date: 2019 |
Indication: Postpartum depression (PPD) |
Category: Other |
|
SL-401
|
8/23/2016
|
|
Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) targeting the interleukin-3 receptor (CD123)
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 8/23/2016/2016
Approval Date: |
Indication: Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) targeting the interleukin-3 receptor (CD123) |
Category: Rare Inherited Disorders |
|
Esketamine
|
8/16/2016
|
7/31/2020
|
Major depressive disorder with imminent risk for suicide
|
Other
|
|
Date of BT Designation Disclosure: 8/16/2016/2016
Approval Date: 2020 |
Indication: Major depressive disorder with imminent risk for suicide |
Category: Other |
|
Kisqali (ribociclib)
|
8/03/2016
|
3/13/2017
|
Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/03/2016/2016
Approval Date: 2017 |
Indication: Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as initial endocrine-based therapy |
Category: Cancer |
|
Kisqali Femara Co-Pack (letrozole and ribociclib)
|
8/02/2016
|
5/04/2017
|
Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced metastatic breast cancer
|
Cancer
|
|
Date of BT Designation Disclosure: 8/02/2016/2016
Approval Date: 2017 |
Indication: Postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced metastatic breast cancer |
Category: Cancer |
|
Pracinostat
|
8/01/2016
|
|
In combination with azacitidine of patients with newly diagnosed acute myeloid leukemia unfit for intensive chemotherapy
|
Cancer
|
|
Date of BT Designation Disclosure: 8/01/2016/2016
Approval Date: |
Indication: In combination with azacitidine of patients with newly diagnosed acute myeloid leukemia unfit for intensive chemotherapy |
Category: Cancer |
|
Darzalex (daratumumab)
|
7/26/2016
|
11/21/2016
|
Patients with multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone
|
Cancer
|
|
Date of BT Designation Disclosure: 7/26/2016/2016
Approval Date: 2016 |
Indication: Patients with multiple myeloma who have received at least one prior therapy, in combination with bortezomib and dexamethasone |
Category: Cancer |
|
V920
|
7/25/2016
|
|
Ebola Zaire
|
Infectious Disease
|
|
Date of BT Designation Disclosure: 7/25/2016/2016
Approval Date: |
Indication: Ebola Zaire |
Category: Infectious Disease |
|
SPK-9001
|
7/21/2016
|
|
Hemophilia B.
|
Rare Inherited Disorders
|
|
Date of BT Designation Disclosure: 7/21/2016/2016
Approval Date: |
Indication: Hemophilia B. |
Category: Rare Inherited Disorders |
|
Zolgensma (onasemnogene abeparvovec-xioi)
|
7/20/2016
|
5/24/2019
|
Spinal muscular atrophy (SMA) Type 1 in children less than two years old
|
Other
|
|
|