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Myriad Genetics Seeking Additional FDA Approval for BRACAnalysis CDx

NEW YORK – Myriad Genetics announced that it will file a supplementary premarket approval application with the US Food and Drug Administration for its BRACAnalysis CDx to be used to identify which metastatic, castration-resistant prostate cancer patients have germline BRCA mutations and may benefit from treatment with olaparib (AstraZeneca and Merck’s Lynparza). 

The announcement to pursue regulatory approval followed release of the topline results of the Phase III PROfound study which compared olaparib versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed treatment with a new hormonal agent and have germline and somatic mutations in homologous recombination repair genes. Patients with these mutations and treated with olaparib experienced a statistically significant and clinically meaningful improvement of radiographic progression-free survival than those receiving enzalutamide or abiraterone acetate.

"The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer," Myriad Chief Medical Officer Johnathan Lancaster said in a statement. 

BRCA1 and BRCA2 are involved in homologous recombination. The National Comprehensive Cancer Network Guidelines recommend testing all men with newly diagnosed, high risk, very high risk, regional, or metastatic prostate cancer for germline BRCA mutations.