Novartis Submits sBLA for Tisagenlecleucel in Adults With Relapsed/Refractory DLBCL

October 31, 2017 – Novartis has filed a supplemental biologics license application (sBLA) with the FDA to expand the indication for tisagenlecleucel to include adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT). The FDA granted a breakthrough therapy designation for tisagenlecleucel in this population in April 2017. The agency approved the chimeric antigen receptor … (leggi tutto)