By Michael Dabaie
Myriad Genetics said it submitted a supplementary premarket approval application to the U.S. Food and Drug Administration.
The sPMA is for the company's BRACAnalysis CDx test as a companion diagnostic to AstraZeneca and Merck & Co.'s (MRK) Lynparza for men with metastatic castration-resistant prostate cancer.
AstraZeneca and Merck said Tuesday the supplemental New Drug Application for Lynparza was been accepted and granted priority review by the FDA.
Myriad said the filing for BRACAnalysis CDx is based on the positive clinical results from the PROfound study.
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