In July, the first chimeric antigen receptor T (CAR-T) cell–based immunotherapy received breakthrough drug designation from the US Food and Drug Administration. The University of Pennsylvania's CTL019, developed in partnership with Novartis, received the designation for its program in relapsed and refractive acute lymphoblastic leukemia (ALL). Early-stage clinical trial results of 27 ALL patients (22 children and 5 adults) reported last December at the annual meeting of the American Society of Hematology showed that 89% of patients had a complete response, although five relapsed, apparently due to non-CD19-bearing tumors. Competition in the field has been heating up. Kite Pharma of Santa Monica, California, and Juno Therapeutics of Seattle have CAR-T cell clinical programs. Preclinical CAR-T cell programs have been launched by Paris-based Cellectis and bluebird bio of Cambridge, Massachusetts, in partnership with Pfizer of New York and Summit, New Jersey–based Celgene, respectively.