BioCentury
ARTICLE | Regulation

ODAC heeds Pazdur, recommends pulling Keytruda as third-line gastric cancer therapy

In hepatocellular carcinoma, ODAC votes favor Keytruda but not Opdivo

April 30, 2021 1:06 AM UTC

FDA’s Oncologic Drugs Advisory Committee Thursday voted 6 to 2 to recommend withdrawal of accelerated approval for Merck’s Keytruda as third-line treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

The panel also voted on whether to retain accelerated approval for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) and Opdivo nivolumab from Bristol Myers Squibb Co. (NYSE:BMY) for second-line hepatocellular carcinoma, supporting Keytruda while recording a mixed vote on Opdivo...