14 Aug 2023 • "On August 11, 2023, the Food and Drug Administration (FDA) granted approval to the fixed dose combination of niraparib and abiraterone acetate along with prednisone for treating adult patients with castration-resistant prostate cancer (CRPC) who have deleterious or suspected deleterious BRCA mutations. This decision was based on the results from the MAGNITUDE trial's Cohort 1 (NCT03748641), a randomized, double-blind, placebo-controlled study involving 423 patients with homologous recombination repair (HRR) gene-mutated mCRPC. The study found a significant improvement in rPFS among patients with BRCA mutations who received niraparib and abiraterone acetate plus prednisone, with a median rPFS of 16.6 months compared to 10.9 months in the placebo group (HR 0.53; p=0.0014). An exploratory OS analysis also favored the investigational arm for BRCA-mutated patients, although the difference was not statistically significant. The overall improvement in the intention to treat (ITT) HRR population's rPFS was primarily attributed to the results seen in patients with BRCA mutations, as those with non-BRCA HRR mutations did not show a significant benefit. The study demonstrated the efficacy of the niraparib and abiraterone acetate combination for BRCA-mutated CRPC patients, leading to the FDA's approval for this indication. Source: FDA | Read full story