USA – FDA calls in adcomm to review six more oncology accelerated approvals

After drugmakers voluntarily withdrew four indications for their cancer drugs in recent months, the US Food and Drug Administration (FDA) on Thursday said it would convene an advisory committee to review six more oncology indications with accelerated approval after confirmatory trials failed to verify their clinical benefit.

Over the course of three days in April, FDA’s Oncology Drugs Advisory Committee (ODAC) will review six indications for Roche’s Tecentriq (atezolizumab), Merck’s Keytruda (pembrolizumab) and Bristol Myers Squibb’s Opdivo (nivolumab) in breast, urothelial, gastric and hepatocellular cancers. The committee will receive updates on the results of the confirmatory trials and the status of any ongoing or planned trials for each indication and will be tasked with making recommendations on whether the indications should remain approved while additional trials are conducted.

All three of the drugs were among the four that recently had indications voluntarily withdrawn by their manufacturers. The withdrawals and review of the six additional indications are part of an industry-wide review of oncology accelerated approvals that marks a shift in FDA’s oversight of accelerated approvals. (RELATED: Industry-wide accelerated approval review yields four withdrawalsRegulatory Focus 10 March 2021)…