Pune, India | December 15, 2025
The U.S. FDA has approved niraparib combined with abiraterone acetate and prednisone for adults with BRCA2 prostate cancer, specifically those with metastatic castration-sensitive disease. Clinical trials showed significant improvements in progression-free survival and overall survival. This approval represents an important step forward in the treatment of genetically driven, aggressive prostate cancers.
The AMPLITUDE study enrolled 696 patients with metastatic castration-sensitive prostate cancer carrying homologous recombination repair gene mutations. Patients received either niraparib plus abiraterone acetate and prednisone or placebo with abiraterone and prednisone, alongside standard androgen deprivation therapy. This design enabled researchers to measure the therapy’s impact on BRCA2 prostate cancer directly.
Results showed that patients with BRCA2 prostate cancer had a 54% reduction in disease progression risk compared with the placebo group. Median progression-free survival for the treatment group was not reached, while the placebo group had a median of 26 months. These outcomes demonstrate the therapy’s efficacy in genetically defined prostate cancers.
Overall survival analysis also favored the treatment arm. Among 323 patients with BRCA2 prostate cancer, 36 deaths occurred in the niraparib group, compared with 55 deaths in the placebo group. These findings confirm the therapy’s potential to extend life in patients with high-risk cancer.
The FDA-approved regimen includes 200 mg niraparib, 1,000 mg abiraterone acetate, and 5 mg prednisone daily. Treatment continues until disease progression or unacceptable toxicity occurs. Concurrent androgen deprivation therapy remains essential, either via gonadotropin-releasing hormone analogs or prior bilateral orchiectomy.
Healthcare providers are advised to monitor patients for serious adverse events. This includes myelodysplastic syndrome, acute myeloid leukemia, fluid retention, hepatotoxicity, hypokalemia, cardiovascular reactions, and embryo-fetal toxicity. Early recognition of side effects ensures safer management for BRCA2 prostate cancer patients.
The FDA granted priority review and used an Assessment Aid to accelerate the evaluation process, reflecting its commitment to timely access to treatments for life-threatening conditions. Experts emphasize that BRCA2 prostate cancer is aggressive and often resistant to standard therapy, highlighting the importance of targeted treatment strategies.
By targeting the DNA repair pathway, niraparib exploits genetic vulnerabilities in cancer cells, while abiraterone acetate strengthens treatment effectiveness. This dual mechanism exemplifies precision oncology approaches for BRCA2 prostate cancer, improving both progression-free and overall survival outcomes.
Patients and caregivers are encouraged to report any adverse events via the FDA MedWatch system. Oncologists may contact the FDA’s Oncology Center of Excellence for guidance on investigational treatments. The approval of niraparib combined with abiraterone acetate and prednisone offers a promising new treatment option for patients with BRCA2 prostate cancer.
This therapy provides hope by delaying disease progression and enhancing survival. It also emphasizes the importance of genetic testing and early identification of BRCA2 mutations to optimize individualized treatment. As precision medicine continues to advance, this combination therapy sets a new standard for personalized care for BRCA2 prostate cancer patients.
