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Friday, December 12, 2025

J&J's Akeega granted expanded indication in prostate cancer

Johnson & Johnson's Akeega (niraparib/abiraterone acetate) has received regulatory approvals and is seeking expanded use in prostate cancer, already approved for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) and now under review for earlier-stage, hormone-sensitive prostate cancer (mHSPC) with HRR gene alterations, aiming to delay progression in high-risk patients with this specific genetic profile. The drug, a dual-action tablet combining a PARP inhibitor (niraparib) and an androgen blocker (abiraterone), showed significant benefit in Phase 3 trials for both mCRPC and mHSPC populations with these mutations.

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