Posted by Michael Wonder on 12 Jul 2017
Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat paediatric, young adult r/r B-cell ALL
13 July 2017 - Positive ODAC recommendation is latest milestone for CTL019 program that started through collaboration with the University of Pennsylvania.
Novartis announced today that the US FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) paediatric and young adult patients with B-cell acute lymphoblastic leukaemia (ALL).
"The panel's unanimous recommendation in favour of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need," said Bruno Strigini, CEO, Novartis Oncology. "We're very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review."
