FDA grants Cellectis’ UCART22 ODD and RPDD status for ALL treatment

Cellectis announced that the U.S. Food and Drug Administration or FDA has granted Orphan Drug or ODD and Rare Pediatric Disease Designation, RPDD, Status to UCART22 product candidate for the treatment of Acute Lymphoblastic Leukemia, ALL.Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis said: “We are excited that the FDA granted UCART22 both ODD and RPDD Status in the treatment of acute lymphoblastic leukemia. This decision represents additional evidence of the potential of UCART22 to bring a much-needed therapeutic option to these patients with ALL. There is an urgent need to develop new therapies for ALL for patients who are not candidates for HSCT or relapse after CD19 directed CAR T-cell therapies and/or HSCT.” About Cellectis