BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

 BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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