As FDA, Merck clash over patient access concerns . . .

FDA Panel Votes To Remove Keytruda’s Gastric Cancer Indication

By Beth Wang / April 30, 2021 at 3:20 PM
FDA’s panel of oncology advisers on Thursday (April 29) voted 6-2 against letting Merck Sharpe & Dohme’s Keytruda (pembrolizumab) keep its accelerated approval status as a third-line treatment for gastric cancer. The decision followed a tense discussion in which Merck and FDA officials clashed over whether and how gastric cancer patients would still be able to access the drug for third-line therapy if the accelerated approval status were revoked. Merck maintained that Keytruda should be able to keep its indication...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.