FDA
Akeega OK’d for BRCA2-mutated metastatic castration-sensitive prostate cancer
On December 12, 2025, FDA approved Akeega (niraparib and abiraterone) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic castration-sensitive prostate cancer (mCSPC), as determined by an FDA-approved test.
Efficacy
Efficacy was evaluated in the randomized, double-blind AMPLITUDE trial (NCT04497844) involving 696 patients with homologous recombination repair (HRR) gene-mutated (HRRm) mCSPC. Patients were randomized (1:1) to receive niraparib and abiraterone acetate plus prednisone (AAP) or placebo and AAP. All patients also received continued androgen deprivation therapy.
Major efficacy outcome measure was investigator-assessed radiographic progression-free survival (rPFS). Overall survival (OS) was an additional efficacy outcome.
The trial demonstrated a statistically significant improvement in rPFS for niraparib and AAP compared with placebo and AAP in the overall population of patients with HRRm. In an exploratory analysis of 323 patients with BRCA2m, the hazard ratio (HR) for rPFS was 0.46 (95% confidence interval [CI], 0.32-0.66) with median rPFS not estimable [NE] (95% CI, 41, NE) for niraparib and AAP and 26 months (95% CI, 18-28) for placebo and AAP. In an exploratory analysis in 373 patients with non-BRCA2m, the HR for rPFS was 0.88 (95% CI, 0.63-1.24), indicating that the overall improvement was primarily attributed to the results seen in patients with BRCA2m.
At the first interim analysis for OS, 91 deaths had occurred in the BRCA2m population, including 36 (22%) on the niraparib and AAP arm and 55 (34%) on the placebo and AAP arm.
Safety
The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia; myelosuppression; hypokalemia; fluid retention, and cardiovascular adverse reactions; hepatoxicity; adrenocortical insufficiency; hypoglycemia; increased fractures and mortality in combination with radium Ra 223 dichloride; posterior reversible encephalopathy syndrome; and embryo-fetal toxicity.
Recommended dose
The recommended dosage is 200 mg niraparib and 1,000 mg abiraterone acetate orally once daily in combination with 5 mg prednisone once daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should’ve had bilateral orchiectomy.
Sources:
FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer. [News release]. 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-niraparib-and-abiraterone-acetate-plus-prednisone-brca2-mutated-metastatic-castration
Akeega (niraparib and abiraterone acetate) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216793s001lbl.pdf Revised December 2025. Accessed December 19, 2025.