FDA OKs Niraparib and Abiraterone Acetate for BRCA+ Metastatic CRPC


The first and only dual action tablet, niraparib and abiraterone acetate, is now available for use in patients with BRCA-positive, metastatic castration-resistant prostate cancer following its approval by the FDA.

The FDA has approved the use of dual action tablet niraparib and abiraterone acetate (Akeega) plus prednisone for a population of patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer, according to a press release from Janssen Pharmaceutical Companies.

The FDA approval of niraparib and abiraterone acetate was based on data from the phase 3 MAGNITUDE trial.

The FDA approval of niraparib and abiraterone acetate was based on data from the phase 3 MAGNITUDE trial.

The approval was based on data from the phase 3 MAGNITUDE trial (NCT03748641), in which patients who received niraparib and abiraterone acetate plus prednisone achieved a 47% decreased risk of radiographic progression-free survival (rPFS; HR, 0.53; P = .001). Investigators also reported a median rPFS by independent central review of 19.5 months in the experimental arm vs 10.9 months with placebo (HR, 0.55; 95% CI, 0.39-0.78); the median follow-up was 24.8 months at the second interim analysis.

Other improvements in the experimental arm over the control arm included time to symptomatic progression (HR, 0.54; 95% CI, 0.35-0.85) and time to initiation of cytotoxic chemotherapy (HR, 0.56; 95% CI, 0.35-0.90). There was also a trend towards improved overall survival in the niraparib/abiraterone acetate arm (HR, 0.88; 95% CI, 0.58-1.34).

“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, a medical oncologist at BC Cancer – Vancouver. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with [niraparib and abiraterone acetate] and to help us understand how we can potentially achieve better health outcomes for patients.”

In terms of safety, serious adverse effects (SAEs) were reported in 41% of those in the experimental arm who bad a BRCA mutation. The most frequent AEs in the experimental and placebo arms, respectively, included musculoskeletal pain (44% vs 42%), fatigue (43% vs 30%), constipation (34% vs 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).

“The approval of [niraparib and abiraterone acetate] brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease," Shelby Moneer, MS, CHES, vice president at Patient Programs and Education, ZERO Prostate Cancer, added. “All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes.”


U.S. FDA Approves AKEEGA™ (niraparib and abiraterone acetate), the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. August 11, 2023. Accessed August 11, 2023. https://bit.ly/3QBbT0d

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