Myriad to Seek FDA Approval of Diagnostic Test to Determine Lynparza Eligibility for mCRPC Patients

Myriad to Seek FDA Approval of Diagnostic Test to Determine Lynparza Eligibility for mCRPC Patients
Myriad Genetics is filing an application with the U.S. Food and Drug Administration requesting the approval of its BRACAnalysis CDx — which identifies inherited BRCA mutations — as a companion diagnostic test for selecting metastatic castration-resistant prostate cancer (mCRPC) patients eligible for Lynparza (olaparib) treatment. The announcement comes after promising results from the Phase 3 PROfound trial (NCT02987543), showing that Lynparza is significantly better than hormone therapy at delaying disease worsening or death in mCRPC patients with BRCA or ATM mutations. “The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” Johnathan Lancaster, chief medical officer of Myriad Genetics, said in a press release. Lynparza is an anti-cancer agent known a
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