Bristol Myers Squibb receives positive CHMP opinion for Opdivo plus Yervoy as the first-line treatment option for patients with unresectable or advanced Hepatocellular Carcinoma

Bristol Myers Squibb announces that the CHMP of the EMA has recommended approval of Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma (HCC), based on results from the Phase 3 CheckMate -9DW trial.

“Hepatocellular carcinoma is the predominant type of liver cancer globally, including in the European Union, and when diagnosed at the advanced or unresectable stage, prognosis and overall survival remain sub-optimal with conventional therapy,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “The positive opinion received by the CHMP is a significant step forward in providing patients with additional treatment options, and we look forward to the upcoming European Commission review and the potential to expand the treatment landscape for adult patients with unresectable or advanced hepatocellular carcinoma.”

Later last year the FDA also accepted the Company’s supplemental Biologics License Application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable HCC and assigned a Prescription Drug User Fee Act goal date of April 21, 2025. The combination of Opdivo plus Yervoy was granted accelerated approval by the U.S. FDA in 2020 based on results from the Phase 2 CheckMate -040 trial and has been an established second-line treatment for patients with advanced HCC.

Bristol Myers Squibb thanks the patients and investigators for their important contributions to the Phase 3 CheckMate -9DW clinical trial.



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