Penn Medicine Developed CAR T Cell Therapy Wins Third FDA Approval

The U.S. Food and Drug Administration (FDA) has expanded its approval for a personalized cellular therapy developed at the University of Pennsylvania’s Abramson Cancer Center, this time for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The accelerated approval was granted today to Novartis for the chimeric antigen receptor (CAR) T-cell therapy Kymriah® (tisagenlecleucel), making it the third indication for the nation’s first personalized cellular therapy for cancer. It remains the only CAR-T cell therapy approved for both adult and pediatric patients.