The U.S. Food and Drug Administration (FDA) has approved Novartis Pharmaceuticals' Kymriah suspension for intravenous infusion for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
"At Novartis, we have a long history of being at the forefront of transformative cancer treatment," CEO Joseph Jimenez said in a statement. "Five years ago, we began collaborating with the University of Pennsylvania and invested in further developing and bringing what we believed would be a paradigm-changing immunocellular therapy to cancer patients in dire need. With the approval of Kymriah, we are once again delivering on our commitment to change the course of cancer care."
Kymriah, the first chimeric antigen receptor T cell (CAR-T) therapy, is a one-time treatment; the drug uses patients’ own T cells to fight cancer. It is a gene therapy, and it’s the first one to be approved by the FDA.
"We are so proud to be part of this historic moment in cancer treatment and are deeply grateful to our researchers, collaborators, and the patients and families who participated in the Kymriah clinical program," Bruno Strigini, CEO of Novartis Oncology, said. "As a breakthrough immunocellular therapy for children and young adults who desperately need new options, Kymriah truly embodies our mission to discover new ways to improve patient outcomes and the way cancer is treated."