Bristol Myers Squibb receives European Commission approval for Opdivo® (nivolumab) and Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
Approval based on the results of the phase 3 CheckMate -9DW clinical trial demonstrating a statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to the investigator's choice of lenvatinib or sorafenib.
' ''The European Commission's approval of Opdivo plus Yervoy adds to the growing body of evidence demonstrating the value of dual immunotherapy and represents an important new treatment option with the potential to prolong survival in patients with hepatocellular carcinoma,'' said Dana Walker, M.D., M.S.C.E., Vice President, Global Opdivo Program Lead, Bristol Myers Squibb.
''This approval marks a crucial milestone in our commitment to improving outcomes for liver cancer patients. We look forward to bringing this new first-line treatment option to patients in the European Union'.
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