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Bristol Myers Squibb statement on Opdivo for hepatocellular carcinoma (liver cancer) U.S. indication.

Read time: 1 mins
Published:13th Mar 2021
The FDA will hold a public meeting of the Oncologic Drugs Advisory Committee (ODAC) between April 27-29, 2021 to discuss accelerated approvals in oncology impacted as part of the Agency’s industry-wide review. On April 29, Bristol Myers Squibb will meet with the Committee to discuss the hepatocellular carcinoma (HCC) indication for Opdivo (nivolumab) monotherapy. “We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “In HCC, despite evolution of the treatment landscape over the past few years, we believe Opdivo continues to address an unmet medical need for patients in the post-sorafenib setting, and we appreciate the opportunity to discuss this in more depth with the Committee.” In 2017, Opdivo was granted accelerated approval by the FDA as a single agent for patients with HCC who have been previously treated with sorafenib. The accelerated approval was based on tumor responses from the Phase 1/II CheckMate -040 trial. CheckMate -459, the subsequent confirmatory randomized study of Opdivo versus sorafenib in the first-line setting, did not achieve statistical significance for its primary endpoint of overall survival (OS) per the pre-specified analysis.
Condition: Liver Cancer
Type: drug

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