OXB announced the European Commission’s approval for the Novartis CAR-T cell therapy, Kymriah (a ground breaking one-time treatment that uses a patient’s own T cells to fight cancer).
The approved indications are for the treatment of paediatric and young adults up to 25 years of age with B-cell acute lymphoblastic leukaemia that is refractory, in relapse post-transplant or in second stage or later relapse. They are also for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Kymriah is the only chimeric antigen receptor T cell (CAR-T) therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies. It was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration.
OXB is the sole manufacturer of the lentiviral vector that encodes the CD19-directed chimeric antigen receptor in Kymriah. It signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products, for which OXB could possibly receive in excess of $100m from Novartis over the next three years. OXB will also receive undisclosed royalties on potential future sales of Novartis CAR-T products, as announced in October 2014.