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 to read full press release/ article | Ref: BMS | Image: Stat News
The post BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML first appeared on PharmaShots.
