NEW YORK – Myriad Genetics said it has submitted a supplementary premarket approval application to the US Food and Drug Administration for myChoice CDx as a companion diagnostic for olaparib (AstraZeneca/Merck's Lynparza) in combination with bevacizumab (Genentech's Avastin).
In January, the FDA accepted AstraZeneca and Merck's supplementary new drug application for the olaparib/bevacizumab combination and granted it priority review for the maintenance treatment of advanced ovarian cancer patients who are responding to first-line platinum chemotherapy with bevacizumab.