Europe – EU approves first CAR-T therapies

European regulators have approved Novartis’ Kymriah and Gilead’s Yescarta, enabling patients to access CAR-T therapies across the region for the first time.

Kymriah (tisagenlecleucel) has been cleared for the treatment of paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (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.

Yescarta (axicabtagene ciloleucel) was also approved for DLBCL and also for primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy.

Both chimeric antigen receptor T cell (CAR T) therapies work by harnessing a patient’s own immune system to fight certain types of blood cancer. During the process, T cells are drawn from a patient’s blood and reprogrammed in the lab to create T cells that are genetically coded to hunt the patient’s cancer cells…