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May 07, 2021

FDA to Scrutinize Merits of Approved Cancer Drugs

On April 27-29, FDA held its first meeting since 2011 to consider the merits of approved cancer drugs that have not shown to extend or improve life. FDA has only held similar meetings on three occasions. 

Drugs from Merck, Roche and Bristol Myers Squibb were the focus of the three-day meeting, where FDA heard presentations from all involved drugmakers. FDA is expected to seek the advice from a panel of cancer experts before making any final decisions on whether to pull any drug approvals. The FDA has only once revoked an accelerated cancer approval. as withdrawals almost always happen voluntarily by the manufacturer.