Novartis has announced that the European Commission (EC) has approved Kymriah® for the treatment of paediatric 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 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 Food and Drug Administration (FDA).
“We are proud that our efforts in CAR-T now offer the European blood cancer community a breakthrough that brings new hope.”
Kymriah, is a living medicinal product, manufactured individually for each patient by reprogramming the patient’s own immune system cells. Kymriah is the only approved CAR-T cell therapy built using the 4-1BB costimulatory domain, which is critical for full activation of the therapy, enhancement of cellular expansion and durable persistence of the cancer-fighting cells.
This approval was based on the review of the only two global registration CAR-T clinical trials, JULIET and ELIANA, which included patients from eight European countries. In these trials, Kymriah demonstrated strong and durable response rates.
Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients. In Europe, ALL accounts for approximately 80% of leukaemia cases among children, and for patients who relapse from standard of care therapies, the outlook is poor.
Liz Barrett, CEO, Novartis Oncology said, “The Kymriah approval is a transformational milestone for patients in Europe in need of new treatment options. Novartis will continue to build a global infrastructure for delivering CAR-T cell therapies where none existed before remaining steadfast in our goal of re-imagining cancer.”
Carl June, MD, the Richard W. Vague Professor in Immunotherapy in the Department of Pathology and Laboratory Medicine at Penn said, “When the University of Pennsylvania and Novartis agreed to work together to develop CAR-T therapy, our main goal was clear and ambitious to address unmet needs for patients and to extend, improve and save lives. We are proud that our efforts in CAR-T now offer the European blood cancer community a breakthrough that brings new hope.”