The FDA has unveiled what it describes as a pilot “concierge service” for oncologists and patients seeking information and assistance with expanded access (EA) to investigational therapies. The two-pronged program is called Project Facilitate, run by the FDA Oncology Center of Excellence, and EA Navigator, which is operated by the Reagan-Udall Foundation for the FDA.…
The FDA says it is making it easier for doctors to access unapproved therapies for cancer patients, but Richard Padzur, MD, is emphatic: the pilot program, called Project Facilitate, only covers drugs in the oncology space. The FDA decided to unveil the new initiative in an early morning press conference here at the American…
Late-breaking studies featured today at this morning’s press briefing as the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting continues included the phase 3 OSLO-COMET trial, the phase 2 EV-201 trial, and a study suggesting clinical trial participation of patients with lung cancer could be increased by revising eligibility criteria. Laparoscopic and open…
Only 3% of patients with cancer in the US enrol on a clinical trial – and the American Society of Clinical Oncology (ASCO) is concerned that outdated and restrictive eligibility criteria could be hindering research. The organisation has used its annual meeting in Chicago to call for some of these outmoded eligibility criteria to…
While PD-L1 testing has become commonplace with immuno-oncology treatment, the multitude of available antibodies, cut-offs, and scoring algorithms makes this biomarker anything but uniform and consistent. Developments over this past year in the diagnostic market hint that tumor mutational burden (TMB) may face the same variability challenges as PD-L1: the results from one TMB test…
Christiana Care Health System’s Gene Editing Institute is preparing to file an investigational new drug application (IND) with the US Food and Drug Administration for a clinical trial protocol that will use CRISPR genome editing to improve the efficacy of chemotherapy for KRAS-positive non-small-cell lung cancer (NSCLC) patients. The protocol involves using CRISPR-Cas9 gene…
ASCO recently announced a new task force aimed at reducing disparities and improving outcomes for patients and survivors of cancer who live in rural communities. The new Rural Cancer Care Task Force will identify opportunities to close the rural cancer care gap and implement strategies to improve rural cancer care in the United States. …
Executive Summary Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry. Calls for the US Food and Drug Administration to clarify its flexibility…
Executive Summary While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.Timetable at the Central Station Efforts to streamline the US Food and Drug Administration’s expanded access program may be hindered by legal protections that the drugs’…
Although study findings have identified tumor mutational burden (TMB) as an important factor in responses to cancer therapy, establishing a definition for expression of this biomarker and harmonizing assays to measure it have proved challenging, according to Naiyer A. Rizvi, MD. Plasma assays for determining TMB are becoming more diagnostically relevant, said Rizvi, director…
