Expanded EU Opdivo approval for B-MS
US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) – one of the major players in the fast-emerging immune-oncology space – scored another hit this week as it became the first and only programmed death-1 (PD-1) inhibitor approved for a hematologic malignancy in the European Union (EU).
The European Commission approved the drug for adults with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin.
This milestone marks the sixth EU approval for Opdivo in four distinct cancer types in less than two years. The latest approval is based on the overall response rate, as demonstrated by data from an integrated analysis of two trials, CheckMate -205 and CheckMate -039.
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