FDA to Discuss Fates of Half a Dozen Cancer Drugs Next Week

April 23, 2021

The Food and Drug Administration has set a three-day meeting from April 27th to the 29th where a host of oncologists, patient advocates, and regulators will discuss the fates of six oncology drugs. Although early results appeared promising, additional required studies have not been completed. Meeting attendees will discuss whether or not these drugs should be allowed to carry FDA approval.

“The meeting marks the most significant step yet in an effort by the FDA to re-evaluate speedy approvals given to cancer drugs in recent years. These so-called accelerated approvals are granted as part of a pathway the FDA created to clear medicines for serious diseases more quickly than they would be otherwise. They’re given based on the impact drugs have on a “surrogate” marker thought to predict a real benefit such as a longer life. But they’re meant to be conditional, and withdrawn if developers can’t confirm those benefits in further testing.” Read more here.

(Source: Ben Fidler, BioPharma Dive, 3/11/21)

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