Trade Name (Agent): Rindopepimut (Rintega)
Sponsor: Celldex
Date of BT Designation Disclosure: 2/23/2015
Indication: Glioblastoma (GBM)
Category: Cancer
Trade Name (Agent)
Sponsor
Date of BT Designation Disclosure
Approval Date
Indication
Category
Trade Name (Agent): Rindopepimut (Rintega)
Sponsor: Celldex
Date of BT Designation Disclosure: 2/23/2015
Indication: Glioblastoma (GBM)
Category: Cancer
Trade Name (Agent): MPDL3280A
Sponsor: Genentech/Roche
Date of BT Designation Disclosure: 2/01/2015
Indication: Non-small cell lung cancer
Category: Cancer
Trade Name (Agent): Ivacaftor (Kalydeco)
Sponsor: Vertex
Date of BT Designation Disclosure: 12/15/2012
Indication: CF combination therapy
Category: Rare Inherited Disorders
Trade Name (Agent): PVS-RIPO
Sponsor: Duke Medicine
Date of BT Designation Disclosure: 5/15/2016
Indication: Recurrent glioblastoma multiforme (GBM)
Category: Cancer
Trade Name (Agent): SHP621 (budesonide oral suspension, or BOS)
Sponsor: Shire
Date of BT Designation Disclosure: 6/13/2016
Indication: Eosinophilic esophagitis (EoE)
Category: Rare Inherited Disorders
Trade Name (Agent): Zepatier (Grazoprevir/Elbasvir)
Sponsor: Merck
Date of BT Designation Disclosure: 4/08/2015
Indication: Chronic hepatitis C genotype 4
Category: Infectious Disease
Trade Name (Agent): Ivacaftor (Kalydeco)
Sponsor: Vertex
Date of BT Designation Disclosure: 2014
Indication: CF monotherapy, patients 2 years and older with one of the following CFTR gene mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H
Category: Rare Inherited Disorders
Trade Name (Agent): Ivacaftor (Kalydeco)
Sponsor: Vertex
Date of BT Designation Disclosure: 2014
Indication: CF monotherapy, patients 6 years or older with R117H mutationin CFTR gene
Category: Rare Inherited Disorders
Trade Name (Agent): SPK-9001
Sponsor: Pfizer/Spark
Date of BT Designation Disclosure: 7/21/2016
Indication: Hemophilia B.
Category: Rare Inherited Disorders
Trade Name (Agent): V920
Sponsor: Merck
Date of BT Designation Disclosure: 7/25/2016
Indication: Ebola Zaire
Category: Infectious Disease
Trade Name (Agent): Pracinostat
Sponsor: MEI Pharma
Date of BT Designation Disclosure: 8/01/2016
Indication: In combination with azacitidine of patients with newly diagnosed acute myeloid leukemia unfit for intensive chemotherapy
Category: Cancer
Trade Name (Agent): Esketamine
Sponsor: Janssen
Date of BT Designation Disclosure: 8/16/2016
Approval Date: 7/31/2020
Indication: Major depressive disorder with imminent risk for suicide
Category: Other
Trade Name (Agent): SL-401
Sponsor: Stemline Therapeutics
Date of BT Designation Disclosure: 8/23/2016
Indication: Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) targeting the interleukin-3 receptor (CD123)
Category: Rare Inherited Disorders
Trade Name (Agent): Daclatasvir
Sponsor: BMS
Date of BT Designation Disclosure: 4/25/2013
Indication: Hepatitis C combination therapy
Category: Infectious Disease
Trade Name (Agent): SD101
Sponsor: Scioderm
Date of BT Designation Disclosure: 4/29/2013
Indication: Epidermolysis bullosa
Category: Other
Trade Name (Agent): LIVMARLI (maralixibat)
Sponsor: Shire
Date of BT Designation Disclosure: 6/13/2016
Approval Date: 9/29/2021
Indication: Progressive familial intrahepatic cholestasis type 2 (PFIC2)
Category: Rare Inherited Disorders
Trade Name (Agent): Daclatasvir/asunaprevir combination
Sponsor: BMS
Date of BT Designation Disclosure: 2/24/2014
Indication: Hepatitis C
Category: Infectious Disease
Trade Name (Agent): Esketamine
Sponsor: J&J
Date of BT Designation Disclosure: 1/21/2014
Indication: Treatment resistant depression
Category: Other
Trade Name (Agent): Dabrafenib
Sponsor: GlaxoSmithKline
Date of BT Designation Disclosure: 1/13/2014
Indication: NSCLC w/ BRAF mutation
Category: Cancer
Trade Name (Agent): cPMP (ALXN1011)
Sponsor: Alexion
Date of BT Designation Disclosure: 10/24/2013
Indication: Molybdenum cofactor deficiency (MoCD) type A
Category: Rare Inherited Disorders
Trade Name (Agent): Grazoprevir/Elbasvir
Sponsor: Merck
Date of BT Designation Disclosure: 10/22/2013
Indication: Hepatitis C
Category: Infectious Disease
Trade Name (Agent): Volasertib
Sponsor: Boehringer Ingelheim
Date of BT Designation Disclosure: 9/17/2013
Indication: AML combination therapy
Category: Cancer
Trade Name (Agent): Entinostat
Sponsor: Syndax
Date of BT Designation Disclosure: 9/11/2013
Indication: ER-positive metastatic breast cancer combination
Category: Cancer
Trade Name (Agent): BYM338 (Bimagrumab)
Sponsor: Novartis
Date of BT Designation Disclosure: 8/20/2013
Indication: Sporadic inclusion body myositis (sIBM)
Category: Other
Trade Name (Agent): Drisapersen
Sponsor: GlaxoSmithKline/Prosensa
Date of BT Designation Disclosure: 6/27/2013
Indication: Duchenne muscular dystrophy (DMD)
Category: Rare Inherited Disorders
Trade Name (Agent): Serelaxin
Sponsor: Novartis
Date of BT Designation Disclosure: 6/21/2013
Indication: Acute heart failure
Category: Cardiovascular
Trade Name (Agent): Alecensa (alectinib)
Sponsor: Roche
Date of BT Designation Disclosure: 10/04/2016
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
Trade Name (Agent): Elbit Imaging
Sponsor: Gamida Cell
Date of BT Designation Disclosure: 10/10/2016
Indication: Nicord
Category: Cancer
Trade Name (Agent): Acalabrutinib
Sponsor: AstraZeneca
Date of BT Designation Disclosure: 8/01/2017
Indication: Mantle cell lymphoma for patients who have received at least one prior line of therapy
Category: Cancer
Trade Name (Agent): Venetoclax
Sponsor: Abbvie/Roche
Date of BT Designation Disclosure: 8/01/2017
Indication: Elderly patients with previously untreated Acute Myeloid Leukemia (AML) who are ineligible for intensive chemotherapy
Category: Cancer
Trade Name (Agent): Methylenedioxymethamphetamine (MDMA)
Sponsor: MAPS
Date of BT Designation Disclosure: 8/28/2017
Indication: PTSD
Category: Other
Trade Name (Agent): EB-101
Sponsor: Abeona Therapeutics Inc
Date of BT Designation Disclosure: 8/30/2017
Indication: Recessive Dystrophic Epidermolysis Bullosa (RDEB)
Category: Other
Trade Name (Agent): DAS181
Sponsor: Ansun BioPharma
Date of BT Designation Disclosure: 10/10/2017
Indication: Treatment of lower respiratory tract parainfluenza virus (PIV) infection in immunocompromised patients
Category: Infectious Disease
Trade Name (Agent): Valoctocogene Roxaparvovec
Sponsor: BioMarin
Date of BT Designation Disclosure: 10/26/2017
Indication: Hemophilia A
Category: Rare Inherited Disorders
Trade Name (Agent): Monjuvi
Sponsor: MorpoSys
Date of BT Designation Disclosure: 10/23/2017
Approval Date: 7/31/2020
Indication: Relapsed/Refractory DLBCL who are not eligible for high-dose chemotherapy and autologous stem-cell transplantation
Category: Cancer
Trade Name (Agent): Avelumab in combination with Inlyta (axitinib)
Sponsor: EMD Serono and Pfizer
Date of BT Designation Disclosure: 12/21/2017
Indication: Treatment-naïve patients with advanced renal cell carcinoma (RCC)
Category: Cancer
Trade Name (Agent): Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab)
Sponsor: Merck and Eisai
Date of BT Designation Disclosure: 1/09/2018
Approval Date: 8/11/2021
Indication: Advanced and/or metastatic renal cell carcinoma (RCC)
Category: Cancer
Trade Name (Agent): Upadacitinib (ABT-494)
Sponsor: Abbvie
Date of BT Designation Disclosure: 1/09/2018
Indication: Adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy
Category: Other
Trade Name (Agent): Maribavir (SHP620)
Sponsor: Shire
Date of BT Designation Disclosure: 1/08/2018
Indication: Cytomegalovirus (CMV) infection in transplant patients.
Category: Infectious Disease
Trade Name (Agent): Imcivree (setmelanotide)
Sponsor: Rhythm Pharmaceutical, Inc.
Date of BT Designation Disclosure: 1/07/2016
Approval Date: 11/27/2020
Indication: Pro-opiomelanocortin (POMC) deficiency obesity and obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway (the MC4 pathway)
Category: Rare Inherited Disorders
Trade Name (Agent): Tonmya (TNX-102 SL)
Sponsor: Tonix Pharmaceuticals
Date of BT Designation Disclosure: 12/19/2016
Indication: PTSD
Category: Other
Trade Name (Agent): ABT-530
Sponsor: Abbvie
Date of BT Designation Disclosure: 9/30/2016
Indication: genotype 1 HCV patients who have failed to respond to a previous therapy of direct acting antivirals (or DAAs)
Category: Infectious Disease
Trade Name (Agent): Neridronic acid
Sponsor: Grünenthal and Abiogen Pharma
Date of BT Designation Disclosure: 12/16/2016
Indication: Complex regional pain syndrome (CRPS)
Category: Rare Inherited Disorders
Trade Name (Agent): AMT-060
Sponsor: uniQure
Date of BT Designation Disclosure: 1/20/2017
Indication: Hemophilia B
Category: Rare Inherited Disorders
Trade Name (Agent): Toca 511 & Toca FC
Sponsor: Tocagen
Date of BT Designation Disclosure: 2/23/2017
Indication: Recurrent high grade glioma
Category: Cancer
Trade Name (Agent): Evkeeza (evinacumab-dgnb)
Sponsor: Regeneron Pharmaceuticals, Inc
Date of BT Designation Disclosure: 4/07/2017
Approval Date: 2/11/2021
Indication: Homozygous familial hypercholesterolemia (HOFH)
Category: Rare Inherited Disorders
Trade Name (Agent): RVT-802
Sponsor: Enzyvant
Date of BT Designation Disclosure: 4/17/2017
Indication: Complete DiGeorge Syndrome (cDGS)
Category: Rare Inherited Disorders
Trade Name (Agent): Vonapanitase
Sponsor: Proteon Therapeutics, Inc.
Date of BT Designation Disclosure: 5/10/2017
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
Trade Name (Agent): GMI-1271
Sponsor: GlycoMimetics
Date of BT Designation Disclosure: 5/17/2017
Indication: Adult Relapsed/Refractory Acute Myeloid Leukemia
Category: Cancer
Trade Name (Agent): Balovaptan
Sponsor: Roche
Date of BT Designation Disclosure: 1/29/2018
Indication: Autism spectrum disorder (ASD)
Category: Rare Inherited Disorders
Trade Name (Agent): Burtomab
Sponsor: Y-mAbs Therapeutics, Inc.
Date of BT Designation Disclosure: 6/07/2017
Indication: Pediatric patients with relapsed or refractory neuroblastoma with central nervous system or leptomeningeal metastasis
Category: Cancer
Trade Name (Agent): OMS721
Sponsor: Omeros
Date of BT Designation Disclosure: 6/13/2017
Indication: Immunoglobulin A (IgA) nephropathy
Category: Other
Trade Name (Agent): PTI-428
Sponsor: Proteostasis Therapeutics
Date of BT Designation Disclosure: 3/16/2018
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
Trade Name (Agent): tab-cel
Sponsor: Altara Biotherapeutics Inc.
Date of BT Designation Disclosure: 2/15/2015
Indication: Patients with EBV+ PTLD following allogeneic hematopoietic stem cell transplant
Category: Other
Trade Name (Agent): bb2121
Sponsor: Bristol Myers Squibb and Bluebird Bio
Date of BT Designation Disclosure: 11/04/2017
Indication: Patients with relapsed or refractory multiple myeloma
Category: Cancer
Trade Name (Agent): ALIS (amikacin liposome inhalation suspension)
Sponsor: Insmed Inc.
Date of BT Designation Disclosure: 3/29/2018
Indication: Adult patients with nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex
Category: Other
Trade Name (Agent): Pedmark (sodium thiosulfate)
Sponsor: Fennec Pharmaceuticals Inc.
Date of BT Designation Disclosure: 3/27/2018
Indication: Prevention of cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma (SR-HB)
Category: Other
Trade Name (Agent): SPK-8011
Sponsor: Spark Therapeutics Inc.
Date of BT Designation Disclosure: 2/15/2018
Indication: Patients with hemophilia A.
Category: Rare Inherited Disorders
Trade Name (Agent): Ketamine
Sponsor: Johnson & Johnson
Date of BT Designation Disclosure: 4/16/2018
Indication: Patients with depression
Category: Other
Trade Name (Agent): Ribaxamase (SYN-004)
Sponsor: Synthetic Biologics, Inc.
Date of BT Designation Disclosure: 5/11/2017
Indication: prevention of Clostridium difficile infection
Category: Infectious Disease
Trade Name (Agent): OMS721
Sponsor: Omeros Corporation
Date of BT Designation Disclosure: 4/26/2018
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
Trade Name (Agent): Trumenba (Meningococcal Group B Vaccine)
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 4/23/2018
Indication: Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 1 through 9 years of age
Category:
Trade Name (Agent): Kymriah (tisagenlecleucel)
Sponsor: Novartis Pharmaceutical Corp.
Date of BT Designation Disclosure: 4/18/2017
Indication: Patients with large B-cell lymphoma
Category: Cancer
Trade Name (Agent): Oxlumo (lumasiran)
Sponsor: Alnylam Pharmaceuticals, Inc.
Date of BT Designation Disclosure: 3/12/2018
Approval Date: 11/23/2020
Indication: Primary Hyperoxaluria Type 1 (PH1)
Category: Infectious Disease
Trade Name (Agent): Trastuzumab Deruxtecan (DS-8201)
Sponsor: Daiichi Sankyo
Date of BT Designation Disclosure: 8/29/2017
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
Trade Name (Agent): Balovaptan (RG7314)
Sponsor: Hoffman-La Roche Inc.
Date of BT Designation Disclosure: 1/28/2018
Indication: A vasopressin 1a (V1a) receptor antagonist for patients with autism spectrum disorder (ASD)
Category: Other
Trade Name (Agent): Kymriah (CTL019)
Sponsor: Novartis
Date of BT Designation Disclosure: 4/18/2017
Indication: Adult patients with relapsed and refractory diffuse large B-cell lymphoma, who have failed two or more prior therapies
Category: Cancer
Trade Name (Agent): Korsuva (difelikefalin)
Sponsor: Cara Therapeutics Inc.
Date of BT Designation Disclosure: 6/22/2017
Approval Date: 8/24/2021
Indication: Chronic kidney disease, associated pruritius in hemodialysis patients
Category: Other
Trade Name (Agent): ZX008 (fenfluramine)
Sponsor: Zogenix, Inc.
Date of BT Designation Disclosure: 2/06/2018
Indication: Patients who have seizures associated with Dravet syndrome
Category: Other
Trade Name (Agent): SAGE-217
Sponsor: Sage Therapeutics
Date of BT Designation Disclosure: 2/07/2018
Indication: Patients with major depressive disorder (MDD)
Category: Other
Trade Name (Agent): PF-04965842
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 2/14/2018
Indication: Patients with moderate-to-severe atopic dermatitis (AD)
Category: Other
Trade Name (Agent): Nuplazid (pimavanserin)
Sponsor: Acadia Pharmaceuticals Inc.
Date of BT Designation Disclosure: 2017
Indication: Patients with dementia-related psychosis (DRP)
Category: Other
Trade Name (Agent): Larotrectinib
Sponsor: Loxo Oncology, Inc.
Date of BT Designation Disclosure: 7/13/2016
Indication: Unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments
Category: Cancer
Trade Name (Agent): Advantage Arrest™ Silver Diamine Fluoride 38%
Sponsor: Elevate Oral Care
Date of BT Designation Disclosure: 11/03/2016
Indication: Arrest of tooth decay in children and adults
Category: Other
Trade Name (Agent): GC4419
Sponsor: Galera Therapeutics
Date of BT Designation Disclosure: 2/28/2018
Indication: Reduction of the duration, severity, and incidence of severe oral mucositis induced by radiation therapy
Category: Other
Trade Name (Agent): BIVV009
Sponsor: Bioverativ Inc.
Date of BT Designation Disclosure: 3/06/2018
Indication: Patients with cold agglutinin disease (CAgD)
Category: Other
Trade Name (Agent): Verzenio (abemaciclib)
Sponsor: Eli Lilly and Co.
Date of BT Designation Disclosure: 10/08/2015
Approval Date: 2/26/2018
Indication: Adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy
Category: Cancer
Trade Name (Agent): Quizartinib
Sponsor: Daiichi Sankyo Company, Limited
Date of BT Designation Disclosure: 8/01/2018
Indication: Adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML)
Category: Cancer
Trade Name (Agent): Pitolisant
Sponsor: Harmony Biosciences
Date of BT Designation Disclosure: 5/21/2018
Indication: Excessive daytime sleepiness and cataplexy in patients with narcolepsy
Category: Other
Trade Name (Agent): Lenti-D
Sponsor: Bluebird bio Inc.
Date of BT Designation Disclosure: 5/23/2018
Indication: Cerebral adrenoleukodystrophy
Category: Rare Inherited Disorders
Trade Name (Agent): Tafamidis
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 5/23/2018
Indication: Transthyretin Cardiomyopathy (ATTR-ACT)
Category: Cardiovascular
Trade Name (Agent): Xalkori (crizotinib)
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 5/29/2018
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
Trade Name (Agent): Xalkori (crizotinib)
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 5/29/2018
Approval Date: 1/14/2021
Indication: Patients with relapsed or refractory systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive
Category: Cancer
Trade Name (Agent): Venclexta (venetoclax) + Rituximab
Sponsor: AbbVie Inc. and Genentech Inc.
Date of BT Designation Disclosure: 1/20/2016
Approval Date: 6/08/2018
Indication: Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
Category: Cancer
Trade Name (Agent): HTX-011
Sponsor: Heron Therapeutics, Inc.
Date of BT Designation Disclosure: 6/21/2018
Indication: Postoperative Pain Management
Category: Other
Trade Name (Agent): Zemdri (plazomicin)
Sponsor: Achaogen
Date of BT Designation Disclosure: 5/23/2017
Indication: Antibacterials addressing multi-drug resistant (MDR) gram-negative infections
Category: Other
Trade Name (Agent): AMT-601
Sponsor: uniQure N.V.
Date of BT Designation Disclosure: 6/28/2018
Indication: Patients with severe and moderately severe hemophilia B
Category: Rare Inherited Disorders
Trade Name (Agent): Kisqali (ribociclib)
Sponsor: Novartis Pharmaceuticals Corp.
Date of BT Designation Disclosure: 6/20/2018
Approval Date: 7/18/2018
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
Trade Name (Agent): Trumenba (Meningococcal Group B Vaccine)
Sponsor: Pfizer Inc.
Date of BT Designation Disclosure: 3/20/2014
Approval Date: 10/29/2014
Indication: Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 10 through 25 years of age
Category: Infectious Disease
Trade Name (Agent): Bexsero (Meningococcal Group B Vaccine)
Sponsor: Novartis Vaccines and Diagnostics, Inc.
Date of BT Designation Disclosure: 4/07/2014
Approval Date: 1/23/2015
Indication: Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 10 through 25 years of age
Category: Infectious Disease
Trade Name (Agent): Kalydeco (ivacaftor)
Sponsor: Vertex Pharmaceuticals Inc.
Date of BT Designation Disclosure: 2013
Approval Date: 2/21/2014
Indication: Patients age 6 years and older with cystic fibrosis who have mutations in the CTFR gene
Category: Rare Inherited Disorders
Trade Name (Agent): Imbruvica (ibrutinib)
Sponsor: Pharmacyclics LLC
Date of BT Designation Disclosure: 2/12/2013
Approval Date: 11/13/2013
Indication: Patients with mantle cell lymphoma (MCL)
Category: Cancer
Trade Name (Agent): Imbruvica (ibrutinib)
Sponsor: Pharmacyclics LLC
Date of BT Designation Disclosure: 2/12/2013
Approval Date: 1/29/2015
Indication: Patients with Waldenstrom's macroglobulinemia (WM)
Category: Cancer
Trade Name (Agent): Zykadia (ceritinib)
Sponsor: Novartis Pharmaceuticals Corp.
Date of BT Designation Disclosure: 3/15/2013
Approval Date: 4/29/2014
Indication: Patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib
Category: Cancer
Trade Name (Agent): Xalkori (crizotinib)
Sponsor: PF Prism CV
Date of BT Designation Disclosure: 4/21/2015
Approval Date: 3/11/2016
Indication: Patients with non-small cell lung cancer whose tumors are ROS-1 positive
Category: Cancer
Trade Name (Agent): Rapamune (sirolimus)
Sponsor: PF Prism CV
Date of BT Designation Disclosure: 2015
Approval Date: 5/28/2015
Indication: Patients with lymphangioleiomyomatosis (LAM)
Category: Other
Trade Name (Agent): Yescarta (axicabtagene ciloleucel)
Sponsor: Kite Pharma Inc.
Date of BT Designation Disclosure: 12/07/2015
Approval Date: 10/18/2017
Indication: Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
Category: Cancer
Trade Name (Agent): Kymriah (tisagenlecleucel)
Sponsor: Novartis Pharmaceuticals Corp.
Date of BT Designation Disclosure: 7/07/2014
Approval Date: 8/30/2017
Indication: Pediatric and young adult patients (age 3-25 years) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse
Category: Cancer
Trade Name (Agent): Opdivo (nivolumab)
Sponsor: Bristol-Myers Squibb Company
Date of BT Designation Disclosure: 9/26/2014
Approval Date: 12/22/2014
Indication: Patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600+, a BRAF inhibitor
Category: Cancer
Trade Name (Agent): Opdivo (nivolumab)
Sponsor: Bristol-Myers Squibb Company
Date of BT Designation Disclosure: 9/02/2015
Approval Date: 10/09/2015
Indication: Patients with metastatic non-squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy
Category: Cancer