By Tristan Manalac

Pictured: Janssen headquarters in California/iStock, Sundry Photography
The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation.
According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson.
The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients.
Akeega also led to a trend toward better overall survival, though this effect fell short of statistical significance. The Akeega-based combination likewise significantly improved secondary endpoints such as the time to symptomatic progression and time to initiation of cytotoxic chemotherapy.
In terms of safety, the adverse events in the combination regimen were consistent with the known side effects of each of the component therapies. The most common toxicities were musculoskeletal pain, fatigue, constipation and hypertension—with 15% of patients having to discontinue Akeega due to adverse reactions.
Akeega’s approval “brings an important treatment option to patients with prostate cancer,” Shelby Moneer, vice president of patient programs and education at non-profit ZERO Prostate Cancer, said in a statement. Moneer had not been paid for any media work, according to Janssen’s announcement.
In prostate cancer, Akeega will face off against AstraZeneca’s and Merck’s Lynparza (olaparib), which first entered the space in May 2020, when it won the FDA’s approval for metastatic castration-resistant prostate cancer (mCRPC) in patients with HRR gene mutations. In June 2023, the PARP inhibitor was authorized for use in BRCA-mutated patients as part of a combination regimen with abiraterone and prednisone.
Pfizer’s PARP inhibitor Talzenna (talazoparib) also joined the prostate cancer market in June when it became approved for HRR-mutated mCRPC. Talzenna is approved in combination with Xtandi (enzalutamide), which it had developed in partnership with Astellas.
Akeega’s approval Friday was Janssen’s second oncology win last week. On Thursday, the FDA granted accelerated approval to the company’s bispecific antibody Talvey (talquetamab-tgvs) for the treatment of relapsed or refractory multiple myeloma. The product carries a boxed warning for cytokine release syndrome and neurologic toxicity.