Myriad Files sPMA With FDA for Test to ID Best Responders to Lynparza, Avastin Combination

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).

Although AstraZeneca and Merck are seeking approval for the combination in advanced platinum-sensitive advanced ovarian cancer patients without a predictive biomarker, Myriad has decided to submit its myChoice CDx for FDA review based on data from the PAOLA-1. The test assesses patients for homologous recombination deficiency, and within PAOLA-1 the benefit of olaparib/bevacizumab maintenance therapy was particularly pronounced in those who were HRD positive with BRCA mutations, with median progression-free survival of 37.2 months versus 17.7 months on bevacizumab alone; as well as those who were HRD positive but BRCA mutation-negative, with median progression-free survival of 28.1 versus 16.6 months.

Source: https://www.genomeweb.com/molecular-diagnostics/myriad-files-spma-fda-test-id-best-responders-lynparza-avastin-combination