FDA has approved the BRACAnalysis CDx from Myriad Genetics, Salt Lake City, for use as a companion diagnostic to identify men with metastatic castration-resistant prostate cancer (mCRPC) who are eligible for treatment with Lynparza (olaparib).

Nicole Lambert, Myriad Genetics.

Nicole Lambert, Myriad Genetics.

Lynparza is approved for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Lynparza is a novel poly (ADP-ribose) polymerase (PARP) inhibitor jointly developed and commercialized by AstraZeneca and Merck.

“This approval is our seventh regulatory approval for BRACAnalysis CDx in support of Lynparza, and further demonstrates our commitment to improve the lives of patients with cancer,” says Nicole Lambert, president of Myriad oncology and women’s health. “The BRACAnalysis CDx test provides clinicians with the vital information needed to quickly match patients with an appropriate treatment option.”

BRACAnalysis CDx is the only FDA-approved germline test to identify men with BRCA1 and BRCA2 mutations, a subpopulation of HRR gene mutations.

“Studies have demonstrated that PARP inhibitors are highly effective in men with BRCA1/BRCA2 mutations, in addition to other mutations in HRR pathways. Once we identify who these men are, they will have more options for treatment,” says Todd Cohen, MD, a board-certified urologist and vice president of medical affairs for Myriad urology. “National Comprehensive Cancer Network guidelines recommend that men with metastatic castration-resistant prostate cancer undergo genetic testing alongside an assessment of HRR gene mutations in the tumor.”

For more information, visit Myriad Genetics