BRACAnalysis CDx Test for ovarian cancer with gBRCAm approved by FDA for use with Lynparza.- Myriad Genetics.

Myriad Genetics announced that the FDA has approved BRACAnalysis CDx Test to be used by healthcare professionals to identify patients with advanced ovarian cancer who have a germline BRCA mutation (gBRCAm) and are eligible for first-line maintenance therapy with AstraZeneca�s PARP (poly ADP ribose polymerase) inhibitor, Lynparza (olaparib) following response to platinum-based chemotherapy.

The FDA approvals are based on results from the SOLO-1 trial (ClinicalTrials.gov number: NCT01844986) that tested Lynparza tablets as a maintenance treatment for patients with, advanced-stage BRCAm ovarian cancer who experienced a complete or partial response following first-line standard platinum-based chemotherapy. The study results were published in the New England Journal of Medicine, and the key finding was that Lynparza maintenance therapy cut risk of disease progression or death by 70 percent.

Comment: Lynparza is being commercialized by AstraZeneca and Merck & Co., Inc. (known as MSD outside the US and Canada). The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.It was originally approved by the FDA in 2014.