Prostate Cancer -Feb 2023

Prostate Cancer - Feb 2023

16 Feb 2023: Olaparib + Abiraterone (Oral) / AstraZeneca: Overall survival results from Phase 3 PROpel trial presented at ASCO GU 2023

Summary:

  • The Olaparib + Abiraterone combo posted a median OS of 42.1 months versus 34.7 months for Abiraterone + placebo.
    • The result represents a 7.4-month absolute difference in median OS versus a standard of care (HR – 0.81)
  • Earlier in Dec 2022, FDA extended the PDUFA date on the priority review by 3 months (now expected in mid- march)
    • In EU, the combo was approved in Dec 2022 for the ‘all-comer’ mCRPC population                            

CI Scientists Commentary:

  • The mOS data supports the ‘all-comer’ label for 1L mCRPC, which is expected to receive US FDA approval in mid-march (earlier delayed by 3 months for full review)
    • The ‘all-comer’ label provides an advantage over its competitor Akeega (positive CHMP opinion for BRCA1/2m, EU only)

For full story click here

Share this

Facebook
fb-share-icon
Twitter
Tweet
LinkedIn
Share
Home