FDA Advisory Committee meeting negative on Opdivo post-sorafenib for hepatocellular carcinoma U.S. accelerated approval.BMS

As part of its industry-wide review of accelerated approvals in oncology without confirmatory benefit, the FDA 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 (HCC) 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 tumor responses from the Phase 1/II CheckMate -040 trial. CheckMate -459, the original confirmatory randomized study 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. Four Committee members voted in favor and five voted against maintaining the accelerated approval of Opdivo in this indication while awaiting the results of potential alternate confirmatory trials. The Oncologic Drugs Advisory Committee is a source of independent, expert advice and offers non-binding recommendations to the FDA on marketed and investigational medicines for use in the treatment of cancer. “Immunotherapy is an important next treatment option for patients who have progressed on sorafenib or were unable to tolerate it. We are disappointed with today’s outcome for patients, and we will work closely with the FDA as it completes its review,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “Immunotherapies have changed the way we treat many forms of advanced cancer. We’re proud of the role Opdivo has played in helping to evolve the HCC treatment landscape, and we remain focused on delivering innovative therapies for HCC patients in need.”