Prostate Cancer - Feb 2023
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Prostate Cancer -Feb 2023
24 Feb 2023: Niraparib/ Abiraterone/(Oral) / Janssen: Positive CHMP Opinion for AKEEGA (Niraparib and Abiraterone acetate DAT) + Prednisone for BRCA1/2 mutant mCRPC
Summary:
- The CHMP has recommended approval for Akeega, a fixed-dose combination of J&J’s Niraparib and Abiraterone acetate, in patients with mCRPC
- The positive CHMP opinion is based on the results of the randomized, double-blind, placebo-controlled, Phase 3 MAGNITUDE study
- Niraparib + Abiraterone significantly improved rPFS in all HRR-positive patients
- This improvement was most pronounced in patients with BRCA1/2 gene mutations, where a statistically significant 47 percent risk reduction was observed for rPFS (HR 0.53)
- Akeega will be the first dual-action tablet in the EU for first-line treatment of adults with BRCA-positive mCRPC
- J&J has rights to Niraparib in prostate cancer under the terms of a licensing deal with its original developer Tesaro, signed in 2016, ahead of Tesaro’s acquisition by GSK
- Rights to all other indications including ovarian, fallopian tube, and peritoneal cancers are owned by GSK
CI Scientists Commentary:
- Given the need for mutation testing, it is currently unknown whether Akeega’s two-in-one tablet will be a viable competitor to the “all-comer” combination of Lynparza and Zytiga in the same setting
- The regimen has not been filed in the US yet (expected in 2023)
