FDA Approves Companion Diagnostic for Niraparib Dual Therapy to Treat BRCA-Positive mCRPC

By Zachary Bessette - Last Updated: August 22, 2023

Earlier this month, the US Food and Drug Administration (FDA) granted approval to AKEEGA (niraparib and abiraterone acetate), the first dual-action tablet combining a poly(adenosine diphosphate–ribose) polymerase inhibitor with abiraterone acetate, given with prednisone, for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC).

As the companion diagnostic to this dual therapy, the FDA has approved Foundation Medicine’s tissue-based comprehensive genomic profiling test, FoundationOne® CDx, to identify patients with mCRPC harboring BRCA1/2-positive mutations.

FoundationOne CDx now has more than 30 companion diagnostic indications and analyzes over 300 cancer-related genes for genomic alterations in a patient’s tumor.

“This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA1/2-positive mCRPC,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in a press release.

BRCA1– or BRCA2-mutated mCRPC has had a devastating impact on so many men and their families,” added Shelby Moneer, vice president, Patient Programs and Education, at ZERO Prostate Cancer. “We are so encouraged to see continued progress in advancing treatment options and diagnostics for this devastating condition.”