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 as a PARP inhibitor. These agents block an enzyme called poly (ADP-ribose) polymerase (PARP), which helps repair DNA. By blocking this process, PARP inhibitors keep cancer cells from repairing their damaged DNA, causing their death. The treatment is approved for some ovarian and breast cancers, and appears to work particularly well in people with defects in their DNA repair mechanisms, who accumulate DNA errors faster than those with normal DNA repair. In fact, three out of four Lynparza indications are exclusively for people with inherited BRCA mutations, the most common mutations in DNA repair pathways. For one such indication — first-line maintenance treatment for advanced ovarian cancer patients — patients are first examined with Myriad's companion diagnostic test to confirm they have inherited BRCA mutations and are eligible for Lynparza treatment. The PROfound study compared the efficacy a
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