The Novartis CAR-T cell therapy Kymriah (tisagenlecleucel, formerly CTL019) has received European Commission approval for treatment of paediatric and young adults up to 25 years of age with B-cell acute lymphoblastic leukaemia (pictured) that is refractory, in relapse post-transplantation or in second-stage or later relapse; and for the treatment of adults with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Kymriah, developed by Novartis in collaboration with the University of Pennsylvania, is a one-time treatment that uses a patient’s own T cells to fight cancer, and the only chimaeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. Kymriah was also the first CAR-T cell therapy to be approved by the US Food and Drug Administration (FDA).
Oxford BioMedica is the sole manufacturer of the lentiviral vector that encodes the CD19-directed chimaeric antigen receptor in Kymriah. The group signed an agreement with Novartis in 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other CAR-T products.