Posted by Michael Wonder on 27 Aug 2018
Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah (tisagenlecleucel)
27 August 2018 - The EC approval is based on the first global CAR-T registration trials, which included patients from eight European countries and demonstrated durable responses and a consistent safety profile in r/r paediatric B-cell ALL and r/r DLBCL.
Novartis today announced that the European Commission (EC) has approved Kymriah (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Kymriah developed in collaboration with the University of Pennsylvania (Penn) is a ground-breaking one-time treatment that uses a patient's own T cells to fight cancer, and the only chimeric 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 ever approved by the US FDA.
