Johnson & Johnson announced FDA approval of a label expansion for Akeega (niraparib and abiraterone acetate dual-action tablet; niraparib and abiraterone acetate) plus prednisone (niraparib and abiraterone acetate plus prednisone) for BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC) on December 12th, 2025. Patients are eligible for the therapy following results from an FDA-approved test for genetic alterations.
According to a company press release, FDA approval was based on results from the Phase III AMPLITUDE study, which evaluated niraparib and abiraterone acetate plus prednisone versus a niraparib placebo given with abiraterone acetate and prednisone, the current standard of care. Study results demonstrated that niraparib and abiraterone acetate plus prednisone reduced the risk of radiographic progression or death by 54% relative to the placebo group. Additionally, niraparib and abiraterone acetate plus prednisone also prolonged the time to symptomatic progression by 59%.
Niraparib is designed to selectively inhibit poly polymerase (PARP), while abiraterone acetate is a CYP17 inhibitor. Prior to this approval, both FDA and EMA also approved the treatment for patients with BRCA-mutated metastatic castration-resistant prostate cancer.
“This expanded indication for [niraparib and abiraterone acetate plus prednisone] reflects our commitment to push the boundaries of science and deliver more personalized, effective treatment options across the prostate cancer continuum,” said Mahadi Baig, M.D., M.H.C.M., Vice President, Head of Solid Tumors, U.S. Medical Affairs, Johnson & Johnson Innovative Medicine, in the release. “Supported by strong clinical data, [niraparib and abiraterone acetate plus prednisone] is now the first and only PARP-based precision medicine combination treatment in BRCA2-mutated mCSPC, offering patients hope for more time with a new way to potentially delay their cancer from progressing.”
“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 for the Lank Center of Genitourinary Oncology, Dana-Farber Cancer Institute, in the release. “AMPLITUDE is the first study to show that this precision medicine combination of a PARP inhibitor with an androgen receptor pathway inhibitor delays both radiographic and symptomatic disease progression.”
