Shots:

• The CHMP has recommended the approval of Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L treatment for unresectable MPM and is based P-III CheckMate -743 trial that met its 1EPs of OS
• The opinion for Onureg is based P-III QUAZAR AML-001 study assessing Onureg (300mg- qd) vs PBO in 472 patients in a ratio (1:1) aged ≥55yrs. as frontline oral maintenance therapy for AML in first remission. The study demonstrated mOS (24.7 vs 14.8 mos.) and subgroup analysis showed consistency in OS benefit in either CR or CRi
• If approved- Opdivo + Yervoy and Onureg will be the first new treatment options authorized for EU patients. The EC will now review the CHMP recommendation to approve medicines for EU

Source 1 - Source 2  

Ref: BMS | Image: BMS