Janssen’s Akeega (niraparib and abiraterone acetate) Receives the EC’s Marketing Authorization for Metastatic Castration Resistant Prostate Cancer
Shots:
- The EC has granted marketing authorization for Akeega in the form of a dual-action tablet for mCRPC. The authorization was based on the P-III trial (MAGNITUDE) evaluating niraparib + AA & prednisone or prednisolone vs PBO + abiraterone acetate & prednisone in 765 patients
- The results showed an improvement in rPFS in all HRR+ patients with 47% risk reduction in patients with BRCA1/2 gene mutations. At the median follow-up at 24.8mos. in the BRCA subgroup, rPFS showed a consistent & clinical treatment effect with m-rPFS (19.5 vs 10.9mos.)
- A trend towards improved OS, improvement in TSP & clinical improvement in time-to-initiation of cytotoxic CT. The safety profile was consistent with the known safety profile of each agent, grade 3/4 AEs in patients with HRR gene alterations (67% vs 46.4%) with maintained overall QoL
Ref: Janssen | Image: Janssen
Related News:- Janssen Receives EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Akeega for BRCA1/2 Gene-Mutated mCRPC
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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.
