FDA Advisory Committee to Review Checkpoint Inhibitors Greenlit Under Accelerated Approval

The fate of three cancer immunotherapies that had been authorized under the U.S. Food and Drug Administration’s Accelerated Approval pathway will be determined next week following failures in confirmatory trials.

The FDA’s Oncologic Drugs Advisory Committee will review products approved under the pathway for breast, urothelial, gastric, and hepatocellular cancers. Specifically, the advisory committee will discuss Merck’s Keytruda (pembrolizumab), Bristol Myers Squibb’s Opdivo (nivolumab), and Roche’s Tecentriq (atezolizumab).