Myriad Submits sPMA for BRACAnalysis CDx Test
January 21 2020 - 7:58AM
Dow Jones News
By Michael Dabaie
Myriad Genetics Inc. (MYGN) 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 PLC's (AZN) 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.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 21, 2020 07:43 ET (12:43 GMT)
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