Posted by Michael Wonder on 06 Nov 2017
Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL
6 November 2017 - Submission of application includes data from global, multi-center Phase II ELIANA and JULIET studies, including 6-month JULIET data to be presented at ASH 2017.
Novartis today announced that the company has submitted a marketing authorisation application to the EMA for CTL019 (tisagenlecleucel) for two indications. The application is for the treatment of children and young adults with relapsed or refractory (r/r) B-cell acute lymphoblastic leukaemia and for adult patients with r/r diffuse large B-cell lymphoma who are ineligible for autologous stem cell transplant.
CTL019 is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer.
