Merck Revokes Keytruda Submission for Third-Line Treatment of Gastric Cancer

Merck is withdrawing its accelerated approval application to the FDA for its blockbuster cancer drug Keytruda (pembrolizumab) for third-line treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, following disappointing study results.

This goes against the trend for the drug which has been racking up multiple approvals for cancer indications — more than 25 so far in the U.S. and 15 in the EU.

Merck said it made the voluntary decision in consultation with the FDA following the evaluation of the application by the agency’s Oncologic Drugs Advisory Committee. At an April 29 meeting, the advisory panel’s discussion centered around the drug’s failure to meet its postmarket requirement of demonstrating an overall survival benefit in a phase 3 study.