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FDA panel supports agency push to raise approval bar for certain cancer drugs

April 22, 2022


The Food and Drug Administration appears ready to raise its approval standards for a well-known class of cancer drugs due to concerns they aren’t helping patients live longer, and may be harming them as well.

A panel of FDA outside advisers on Thursday voted 16-0, with one abstention, to recommend randomized, placebo-controlled trials for the drugs, known as PI3 kinase inhibitors, before they’re approved for broader use in blood cancers such as leukemia and lymphoma. The FDA isn’t bound to follow the advice of its advisory committees, but usually does so.

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