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Home » FDA’s Oncology Expert Panel Holds Last Meeting This Week on Accelerated Approvals
FDA’s Oncology Expert Panel Holds Last Meeting This Week on Accelerated Approvals
The FDA’s Oncologic Drugs Advisory Committee assembled yesterday for its third and final meeting this week to discuss accelerated approvals for cancer drugs that didn’t verify their benefit in confirmatory trials, advising the agency to withdraw indications for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) while defending another Keytruda indication.