FDA granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.
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.
