The FDA has approved niraparib and abiraterone acetate (Akeega, Janssen) plus prednisone for the treatment of certain patients with castration-sensitive prostate cancer (CSPC).

Specifically, the treatment is now approved for adults with deleterious or suspected deleterious BRCA2-mutated (BRCA2m) metastatic CSPC as determined using an FDA-approved test. Niraparib and abiraterone acetate — combined in a once-daily dual-action oral agent — was previously approved with prednisone for those with BRCA-positive castration-resistant disease, as reported by Medscape Medical News.

Approval for the new indication was based on survival outcomes in the randomized, double-blind AMPLITUDE trial. In the overall population of 696 patients with homologous recombination repair gene-mutated metastatic CSPC, radiographic progression-free survival (rPFS) was significantly improved in those randomized to receive niraparib and abiraterone acetate plus prednisone (AAP) vs placebo and AAP, according to the FDA approval notice. 

An exploratory analysis of 323 patients with BRCA2m showed that rPFS was not estimable in the treatment group vs 26 months in the placebo group (hazard ratio [HR], 0.46). A separate exploratory analysis of 373 patients without BRCA2m showed that the HR for rPFS was 0.88. This indicated that the overall improvement was primarily attributable to the results in the BRCA2m-positive population.

Overall survival at the first interim analysis was also improved with treatment vs placebo; 91 deaths had occurred in the BRCA2m-positive population, including 36 (22%) in the treatment arm and 55 (34%) in the placebo and AAP arm.

Full prescribing information for the treatment, which will be posted on Drugs@FDA, includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia; myelosuppression; hypokalemia; fluid retention; 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.

The recommended dose is 200 mg of niraparib and 1000 mg of abiraterone acetate once daily in combination plus 5 mg of prednisone once daily until disease progression or unacceptable toxicity. Patients should also concurrently receive a gonadotropin-releasing hormone analog or have undergone bilateral orchiectomy.

The monthly price for this dose of niraparib and abiraterone acetate starts at $18,689.20 according to drugs.com.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.