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

  Ref: BMS | Image: BMS