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FDA Grants Novartis Breakthrough Therapy Designation for CAR-T Cell Treatment The Food and Drug Administration has granted Breakthrough Therapy designation to Novartis’ investigational therapy for treatment of adult relapsed and refractory diffuse large B-cell lymphoma (DLBCL), the company announced Tuesday. The investigational chimeric antigen receptor T cell (CAR-T) therapy, known as CTL019 was first developed by researchers at the University of Pennsylvania. Novartis and Penn entered into a global collaboration for development and commercialization of CAR-T cell therapies in 2012. DLBCL is the most common type of lymphoma, and about 30 percent of all non-Hodgkin’s lymphoma cases in the U.S. are this type, according to the American Society of Clinical Oncology . This type of therapy is personalized for each patient, whereby T cells are collected from the patient’s blood, then genetically engineered to target cancer cells and other B-cells expressing a specific antigen before being reinfused into the body. The decision for the designation was due to data from a multi-center Phase 2 study investigating efficacy and safety of CTL019 in adults with DLBCL who had failed two or more prior treatments. Breakthrough Therapy designation is granted to treatments for serious or life threatening diseases, that provide a substantial improvement over existing therapies based on preliminary clinical evidence, according to FDA guidelines. It also suggests that the FDA will accelerate the development and review of the CAR-T therapy. Previously, the FDA granted the same designation to CTL019 for the treatment of relapsed and refractory B-cell acute lymphoblastic leukemia (ALL) in children and young adult patients. “We are encouraged by the FDA’s recognition in the potential of CTL019 for this indication, which follows our promising studies of this therapy for ALL and the FDA filing by Novartis in pediatric and young adult ALL that received priority reviews,” Carl June, M.D., director of the Center for Cellular Immunotherapies in the Perelman School of Medicine, and the Penn team’s leader, said in a prepared statement. “Work with our collaborators at trial sites across the world is paving a path to bring personalized cell therapies to more patients with these devastating blood cancers.” Results from the current Phase 2 study are expected to be presented at an upcoming medical conference.
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