Myriad Genetics Inc. plans to seek premarket approval from the U.S. Food and Drug Administration for its BRACAnalysis CDx as a companion diagnostic test for cancer drug Lynparza.
The company will file an application with the U.S. regulator to use the test to help identify prostate cancer patients with certain genetic mutations who are eligible for treatment with AstraZeneca PLC and Merck & Co. Inc.'s Lynparza, or olaparib.
BRACAnalysis CDx is already approved as a companion diagnostic test to identify patients with several cancer types, who are eligible to receive treatment with Lynparza.
AstraZeneca and Merck recently released results of a late-stage study, dubbed PROfound, which evaluated the efficacy and safety of Lynparza in treating patients whose castration-resistant prostate cancer had spread to other parts of the body and had the homologous recombination repair gene mutation, or HRRm.
Results showed that Lynparza helped patients with mutations in their BRCA1/2 or ATM genes live longer without radiographic progression, compared to Astellas Pharma Inc. and Pfizer Inc.'s Xtandi, and Johnson & Johnson's Zytiga.
The drug is already approved as maintenance therapy for certain ovarian cancer patients in the EU, U.S. and Japan. In the U.S., Lynparza is also approved to treat patients with BRCA-mutated breast cancer.
Salt Lake City-based Myriad and AstraZeneca have been collaborating for the diagnostic test related to Lynparza since 2007.