Myriad Genetics BRACAnalysis CDx sPMA by FDA for review
Myriad Genetics announced that the FDA has accepted its supplementary premarket approval, or sPMA, application for BRACAnalysis CDx to be used as a companion diagnostic with AstraZeneca's PARP inhibitor Lynparza in patients with HER2-negative metastatic breast cancer. Myriad expects the FDA's priority review process to conclude in the fiscal third-quarter 2018. Myriad's sPMA filing follows positive results from the Phase III OlympiAD trial, which demonstrated that Lynparza significantly reduced the risk of disease progression or death in patients with BRCA-mutated, HER2-negative metastatic breast cancer by 42% compared to standard therapy. The results of the OlympiAD trial were published in the New England Journal of Medicine in June. If approved, BRACAnalysis CDx would be the first and only FDA-approved companion diagnostic for use with a PARP inhibitor to identify HER2-negative metastatic breast cancer patients with a BRCA mutation who would benefit from a PARP inhibitor. The company estimates there are approximately 125,000 patients with metastatic breast cancer who would immediately qualify for the BRACAnalysis CDx test, followed by 60,000 new patients per year on an ongoing basis.