Myriad Genetics Inc. said the U.S. Food and Drug Administration approved its diagnostic test that determines whether patients are eligible to receive AstraZeneca PLC and Merck & Co. Inc.'s ovarian cancer drug Lynparza.
Salt Lake City-based Myriad's diagnostic test BRACAnalysis CDx can now be marketed for identifying patients with advanced ovarian cancer who have a germline, or hereditary, mutation of the BRCA genes and are eligible for first-line maintenance treatment with Lynparza following chemotherapy.
Maintenance therapy is a treatment intended to keep cancer from coming back after initial therapy.
Separately, U.K.-based AstraZeneca and Kenilworth, N.J.-based Merck won FDA approval for Lynparza, also known as olaparib, to treat patients with advanced ovarian, fallopian tube or primary peritoneal cancer after first-line platinum-based chemotherapy had completely eradicated or shrunk the tumors.
Myriad's collaboration with AstraZeneca for a diagnostic test related to Lynparza began in 2007. Myriad estimates that each year, more than 20,000 U.S. patients newly diagnosed with ovarian cancer would qualify for a BRACAnalysis CDx test.