Posted by Michael Wonder on 30 Aug 2017
Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice
30 August 2017 - Novartis also announces innovative collaboration with the US Centers for Medicare and Medicaid Services.
Novartis announced today that the US FDA has approved Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, the first chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukaemia that is refractory or in second or later relapse.
Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient's own T cells to fight cancer. Kymriah is the first therapy based on gene transfer approved by the FDA.
