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Bristol-Myers Squibb's (BMS) Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Receives EU Approval for 1L Intermediate- and Poor-Risk Advanced RCC

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Bristol-Myers Squibb's (BMS) Opdivo (nivolumab) + Low-Dose Yervoy (ipilimumab) Receives EU Approval for 1L Intermediate- and Poor-Risk Advanced RCC

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  • The approval is based on P-III CheckMate-214 study results assessing Opdivo (3mg/kg) + low-dose Yervoy(1mg/kg) vs sunitinib (50mg- qd) in patients with previously untreated advance RCC
  • P-III Checkmate-214 study results: ORR (41.6% vs 26.5%); CRR (9.4% vs 1.2%); Grade 3 or 4 adverse events (65% vs 76%)
  • Opdivo (nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor targeted for cancer cells- and is approved in 65 countries including the US- EU- Japan- China

Ref: Bristol-Myers Squibb | Image: Bristol-Myers Squibb


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