Rafael Pharmaceuticals Inc. said FDA has granted an orphan drug designation to CPI-613, the company’s lead Altered Energy Metabolism Directed drug candidate, for the treatment of peripheral T-cell lymphoma.
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.
