FDA Grants Priority Review to CTL019 for ALL

March 29, 2017 – The FDA has granted a priority review designation to tisagenlecleucel-T (CTL019) as a treatment for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL), making it the first CAR T-cell therapy to enter regulatory review. The biologics license application (BLA) for tisagenlecleucel-T is based primarily on findings from the global, phase II ELIANA study along with a multicenter trial conducted in the United States … (leggi tutto)