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FDA grants priority review, breakthrough therapy designation to Opdivo-Yervoy combination for HCC
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The FDA granted the combination of nivolumab and ipilimumab priority review and breakthrough therapy designation for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib, according to a company-issued press release.
The agency based its decision, in part, on data from the phase 1/phase 2 CheckMate 040 trial, presented at this year’s ASCO Annual Meeting. A cohort of patients with advanced HCC — all of whom previously had received sorafenib (Nexavar, Bayer) — demonstrated an objective response rate of 31% with a median duration of response of 17.5 months with the combination of the PD-1 immune checkpoint inhibitor nivolumab (Opdivo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb).
“The FDA’s acceptance of our application for Opdivo plus Yervoy represents important progress for patients with liver cancer in the United States, where hepatocellular carcinoma is the fastest rising cause of cancer-related death,” Ian M. Waxman, MD, development lead of gastrointestinal cancers at Bristol-Myers Squibb, said in the press release. “Despite recent advances, hepatocellular carcinoma remains a difficult-to-treat cancer and patients are in need of additional effective treatment options. We look forward to working with the FDA to bring the potential of a dual immuno-oncology therapy to these patients for the first time.”
The FDA set a Prescription Drug User Fee Act goal date for this application of March 10.