Posted by Michael Wonder on 30 Apr 2021
Bristol Myers Squibb statement on FDA Advisory Committee meeting on Opdivo post sorafenib hepatocellular carcinoma U.S. indication
29 April 2021 - As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the U.S FDA today convened a public meeting of the Oncologic Drugs Advisory Committee to discuss impacted indications, including the U.S. indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma who have been previously treated with sorafenib.
Approval for this indication was originally granted by the FDA in 2017 under the Agency’s accelerated approval program based on tumour responses from the Phase 1/2 CheckMate-040 trial.
CheckMate-459, the original confirmatory randomised trial of Opdivo versus sorafenib in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis.
