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
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