FDA Grants Tisagenlecleucel Priority Review for DLBCL

January 17, 2018 – The FDA has granted a priority review to a supplemental biologics license application (sBLA) for the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for or relapse after autologous stem cell transplant (ASCT). The sBLA is based on the phase II JULIET study, in which the CD19-directed therapy tisagenlecleucel reached an overall response … (leggi tutto)