Janssen’s Akeega (niraparib and abiraterone acetate) Receives the US FDA’s Approval for the Treatment of Prostate Cancer
Shots:
- The approval was based on the P-III trial (MAGNITUDE) evaluating Akeega (200mg, qd) + prednisone vs PBO + abiraterone acetate + prednisone (AAP) in a ratio (1:1) in 765 patients showed a 47% risk reduction for rPFS
- At 2nd interim analysis with median follow-up at 24.8mos. in the BRCA+ subgroup, rPFS by central review showed a consistent trend favoring Akeega + prednisone with a m-rPFS (19.5 vs 10.9mos.), improvement in 2EPs of time to symptomatic progression (TSP) and time to initiation of cytotoxic chemotherapy (TCC) with an improvement in OS
- The safety profile was consistent with the known safety profile of each FDA-approved monotx., permanent discontinuation due to an adverse reaction was reported in 15% of patients
Ref: Janssen | Image: Janssen
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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.
