Myriad Asks FDA to Approve myChoice CDx to Find Potential Lynparza Candidates

Myriad Asks FDA to Approve myChoice CDx to Find Potential Lynparza Candidates
Myriad Genetics submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of its myChoice CDx test to identify ovarian cancer patients likely to benefit from first-line maintenance therapy with Lynparza (olaparib) in combination with bevacizumab. The supplementary premarket approval (sPMA) application follows the FDA's granting of priority review status to a request by AstraZeneca and Merck to approve Lynparza and bevacizumab for women with advanced ovarian cancer who respond to first-line platinum-based chemotherapy. Merck is known as MSD outside the U.S. and Canada. Both submissions were supported by positive results from the PAOLA-1 Phase 3 trial (NCT02477644), which showed that the combination significantly delayed disease progression or death compared with bevacizumab alone, a
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