Logo

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

Share this

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  

Ref: BMS | Image: BMS

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions