Myriad Genetics has submitted a supplementary premarket approval application to FDA for its myChoice CDx test to help identify women with advanced ovarian cancer who are potential candidates for maintenance therapy with Lynparza (olaparib) in combination with bevacizumab.
Richard Pazdur, FDA’s top oncologist who last week received a battlefield promotion to the role of director of the FDA Center for Drug Evaluation and Research, is described as a stabilizing figure respected by major patient groups, oncology professional societies, and the industry.
