US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca chose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.
AstraZeneca PLC will likely have to convince the US Food and Drug Administration's Oncologic Drugs Advisory Committee that the company's poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza (olaparib) demonstrated a clinically meaningful impact on progression-free survival (PFS) in pancreatic cancer patients to score a supplemental approval.
ODAC will convene for a half-day discussion on the morning of 17 December to specifically assess Lynparza for the maintenance...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
