In a major breakthrough in cellular therapy, FDA has approved the first tumor-infiltrating lymphocyte therapy for patients with unresectable or metastatic melanoma who have received prior treatment, including with checkpoint inhibitors.
Last week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.
