Bristol Myers Squibb is withdrawing from the U.S. market the indication for its immune checkpoint inhibitor Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who were previously treated with sorafenib.
The move follows the FDA’s Oncologic Drugs Advisory Committee voting down Opdivo for this indication in April while scrutinizing checkpoint inhibitors with “dangling” accelerated approval that have not met their post-marketing requirements demonstrating confirmatory benefit (The Cancer Letter, April 30, 2021). The committee voted five to four not to keep Opdivo’s indication after it failed to show clinical benefit in a trial..
The committee also gave the thumbs down to Merck’s Keytruda (pembrolizumab) as a third-line treatment for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 protein and whose disease has progressed with two or more prior lines of therapy.
Merck announced July 7 that it would withdraw this indication for Keytruda.
Opdivo was the first immunotherapy agent to be approved for use under the FDA’s accelerated approval program. Its 2017 accelerated approval was based on tumor responses from its phase 1/2 trial, but a subsequent randomized study of Opdivo vs. sorafenib didn’t achieve statistical significance for its primary endpoint of overall survival.
