Preliminary data from phase II the GALAHAD study showed that approximately 40 percent of patients with DRD in BRCA1/2 receiving treatment with niraparib (300 mg daily) demonstrated an objective response, defined by the Response Evaluation Criteria in Solid Tumors guideline, version 1.1, as a standard measure of tumor response.
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.
