FDA Grants CTL019 Breakthrough Designation for DLBCL

April 18, 2017 – The FDA has granted a breakthrough therapy designation to tisagenlecleucel-T (CTL019) for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after the failure of at least 2 prior therapies, according to Novartis, the developer of the CAR T-cell therapy. The designation is based on results from the multicenter phase II JULIET study (NCT02445248). Novartis intends to present the trial findings at an … (leggi tutto)