Zachary Bessette

GU Oncology Now

Earlier this month, the US Food and Drug Administration (FDA) granted <a href="https://guoncologynow.com/post/fda-approves-dual-therapy-for-treatment-of-brca-positive-mcrpc" target="_blank" rel="noopener">approval to AKEEGA</a> (niraparib and abiraterone acetate), the first dual-action tablet combining a poly(adenosine diphosphate&ndash;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&rsquo;s tissue-based comprehensive genomic profiling test, FoundationOne&reg; 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&rsquo;s tumor.&ldquo;This companion diagnostic specifically will help enable broader access to an important new therapy option in BRCA1/2-positive mCRPC,&rdquo; said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in a <a href="https://www.foundationmedicine.com/press-releases/77d12149-fab5-443c-8e7a-1b46085bb1c2" target="_blank" rel="noopener">press release</a>.&ldquo;BRCA1&ndash; or BRCA2-mutated mCRPC has had a devastating impact on so many men and their families,&rdquo; added Shelby Moneer, vice president, Patient Programs and Education, at ZERO Prostate Cancer. &ldquo;We are so encouraged to see continued progress in advancing treatment options and diagnostics for this devastating condition.&rdquo;

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

Metastatic castration-resistant prostate cancer 

CRPC

The FDA approved Foundation Medicine’s tissue-based comprehensive genomic profiling test to identify patients with mCRPC harboring BRCA1/2-positive mutations.

FDA Approves Companion Diagnostic for Niraparib Dual Therapy

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