US FDA's oncology advisory committee seems to feel Blincyto has potential in minimal residual disease-positive acute lymphoblastic leukemia, but panel was not asked specifically about approval; a decision could hinge on how agency reviewers interpret committee's comments.
The US FDA's Oncologic Drugs Advisory Committee (ODAC) said Amgen Inc.'s Blincyto (blinatumomab) has a "potential benefit" for patients with minimal residual disease (MRD)-positive acute lymphoblastic leukemia (ALL), but the approval prospects for the supplemental indication remain unclear, as the vote should not be viewed as a vote in favor of approval.
ODAC specifically voted 8 to 4 that Amgen's single-arm, Phase II pivotal trial demonstrates "that for patients with ALL in...
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.
