BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) Receive EC’s Approval for 1L Treatment for Unresectable Malignant Pleural Mesothelioma

June 3, 2021 Auto Bot regulatory 0

Shots:

  • The approval is based on P-III CheckMate -743 study assessing Opdivo (3 mg/kg, q2w) + Yervoy (1 mg/kg, q6w) vs CT in patients with previously untreated MPM
  • The trial met its 1EP i.e improvement in OS (26% reduction in risk of death) m-OS (18.1 vs 14.1 mos.), ORR (40% vs 43%), DoR (11.0 vs 6.7 mos.), mPFS (6.8 vs 7.2 mos.). The safety profile of combination treatment was consistent with previous studies in other tumor types
  • The approval allows for use of combination regimens in all 27 member states of EU, Norway, Liechtenstein & Iceland. Additionally, the combination has been approved in 6 countries, including the US & regulatory applications are under review by health authorities

Click here to­ read full press release/ article | Ref: BMS | Image: Fierce Biotech

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