Posted by Michael Wonder on 31 Oct 2017
Novartis submits application to FDA for Kymriah (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy
31 October 2017 - Submission based on updated analyses from global, multi-centre Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017.
Novartis today announced that the company has submitted a supplemental biologics license application to the US FDA for Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).
In April 2017, Novartis received breakthrough therapy designation for r/r DLBCL which, if approved, would be the second indication for Kymriah. In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval five weeks prior to its PDUFA date and was launched for patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia that is refractory or has relapsed at least twice.
