The FDA has approved the combination of niraparib and abiraterone acetate plus prednisone for adult patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC).
Approval is based on results from the phase 3 AMPLITUDE trial, which demonstrated a significant improvement in radiographic progression-free survival with the addition of niraparib to standard abiraterone and prednisone in patients with BRCA2 alterations.
Niraparib is a PARP inhibitor that enables biomarker-selected treatment intensification early in the disease course. Patients should have confirmed deleterious or suspected deleterious BRCA2 mutations prior to treatment initiation.
Clinical Implications:
This approval introduces a precision-based combination option for BRCA2-mutated mCSPC, moving PARP inhibition into the hormone-sensitive setting.
Germline and somatic testing for homologous recombination repair (HRR) mutations, including BRCA2, should be performed at diagnosis of metastatic prostate cancer to inform treatment selection.