FDA Approves Akeega for BRCA2 Mutated Metastatic Prostate Cancer

The Food and Drug Administration approved Akeega, a dual agent tablet combining niraparib and abiraterone acetate, to be given with prednisone for adults whose metastatic castration sensitive prostate cancer carries deleterious or suspected deleterious BRCA2 alterations, the agency and Janssen Biotech said following a company press release from Horsham, Pennsylvania. The action, granted via a supplemental new drug application and reviewed under Priority Review, was announced by Johnson and Johnson on December 12, 2025. Full prescribing information will be posted on Drugs at FDA.

The approval was supported by the Phase 3 AMPLITUDE trial, NCT04497844, a randomized, double blind study that enrolled 696 patients with homologous recombination repair gene mutated metastatic castration sensitive prostate cancer. In AMPLITUDE patients were randomized one to one to receive niraparib plus abiraterone acetate and prednisone or placebo plus abiraterone acetate and prednisone, with all participants continuing androgen deprivation therapy. The trial met its primary endpoint with a statistically significant improvement in radiographic progression free survival for the combination regimen. Company investor materials described the result as a 54 percent reduction in disease progression compared with standard of care. The FDA noted that the overall improvement observed in the homologous recombination repair altered population was primarily attributable to the subgroup of patients with BRCA2 alterations, citing a confidence interval of 95 percent CI 0.63, 1.24 in its summary of the data.

Regulators and the company framed the decision as the first FDA approved precision medicine combination for BRCA2 altered metastatic castration sensitive prostate cancer and as part of a broader trend moving PARP inhibitor based approaches into the hormone sensitive setting for genetically defined patients. The Akeega regimen was previously approved in August 2023 for BRCA altered metastatic castration resistant prostate cancer based on the MAGNITUDE trial, and Johnson and Johnson said additional marketing applications are under review in multiple countries.

The approval has immediate public health implications. It will put pressure on oncology clinics, community health centers, and insurers to scale up BRCA2 testing at diagnosis of metastatic prostate cancer. Access to testing is uneven across the United States, with documented gaps by race, income, geography, and clinic type that could leave many eligible patients unidentified. Payers will now face decisions about coverage for combination therapy, for companion diagnostic testing, and for services such as genetic counseling that are essential to informed care.

Clinicians and patient advocates should scrutinize the full prescribing information when it is posted on Drugs at FDA to assess hazard ratios, absolute benefit, subgroup analyses, and the safety profile that AMPLITUDE generated. Independent peer reviewed publication of the AMPLITUDE data and the regulatory documents will be important for clinicians weighing benefits against toxicities and for policymakers crafting equitable coverage rules.

As precision therapies move earlier in the course of common cancers, the challenge will be ensuring that the infrastructure for testing, counseling, and affordable treatment keeps pace. Without deliberate policy and funding to address testing disparities and out of pocket costs, the promise of targeted care risks widening existing health inequities for men with advanced prostate cancer.