Novartis gets EC approval of its CAR-T cell therapy

Swiss pharma giant Novartis (NOVN: VX) today became the only company with an approved chimeric antigen receptor T cell (CAR-T) cell therapy for pediatric relapsed or refractory (r/r)/B cell acute lymphoblastic leukemia (ALL) and the first to receive approval in two distinct indications in the European Union and the USA.

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 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. Kymriah was also the first CAR-T cell therapy ever approved by the US Food and Drug Administration in the USA, where it costs $475,000 for patients with ALL and $373,000 for DLBCL.