Janssen Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Akeega for BRCA1/2 Gene-Mutated mCRPC
Shots:
- The opinion was based on the P-III study evaluating niraparib (200mg, qd) + abiraterone acetate & prednisone vs PBO + AA & prednisone in a ratio (1:1) in 765 patients with/out certain HRR gene alterations
- Improvement in rPFS in all HRR+ patients & 47% risk reduction for rPFS in patients with BRCA1/2 gene mutations. In the updated 2nd interim analysis, consistent & significant treatment effect in rPFS at a median follow-up of 24.8mos. in the BRCA subgroup with an m-rPFS (19.5 vs 10.9mos.)
- In the BRCA subgroup, improved OS, time to symptomatic progression & consistent improvement of TCC were reported, grade 3/4 AEs for HRR gene alterations (67% vs 46.4%), and AEs leading to treatment discontinuation (10.8% vs 4.7%) & maintained overall QoL
Ref: Janssen | Image: Janssen
Related News:- Janssen Reports P-II Trial Results of Nipocalimab for the Treatment of Severe Hemolytic Disease
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
