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Johnson & Johnson (NYSE: JNJ) Gets FDA OK; AKEEGA Delays BRCA2 mCSPC Progress 59 Percent
AKEEGA plus prednisone reduces risk of progression or death by 54% in BRCA2-mutated metastatic castration-sensitive prostate cancer, addressing a critical unmet medical need, FDA said.
- Dec. 12, 2025 — The U.S. Food and Drug Administration approved the supplemental NDA for AKEEGA plus prednisone to treat BRCA2‑mutated metastatic castration-sensitive prostate cancer, Johnson & Johnson announced.
- Patients with BRCA2-mutated mCSPC face urgent need for therapies, as `There remains an urgent need for novel therapies for patients with BRCA2-mutated mCSPC, who face significantly faster disease progression and often shorter survival compared to those without the mutation,` said Bradley McGregor, M.D., Director of Clinical Research at Dana-Farber Cancer Institute.
- The Phase 3 trial demonstrated AKEEGA plus prednisone reduced risk of progression or death by 50% in 696 participants from 32 countries.
- Safety data show serious adverse reactions in 36% of patients, Grade 3‑4 anemia in 29%, MDS/AML in 0.6%, and recommend weekly, biweekly, monthly CBCs with hematology referral if toxicities persist.
- The label expansion positions AKEEGA as the first FDA‑approved precision medicine combination for BRCA2‑mutated mCSPC, with additional regulatory filings under review globally and Phase 3 evidence from AMPLITUDE supporting treatment choices.
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U.S. FDA approves AKEEGA® as the first precision therapy for BRCA2-mutated metastatic castration-sensitive prostate cancer with 54% reduction in disease progression vs standard of care*
Expanded indication for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone marks the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC
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Total News Sources70
Leaning Left9Leaning Right5Center22Last UpdatedBias Distribution61% Center
Bias Distribution
- 61% of the sources are Center
61% Center
L 25%
C 61%
14%
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