Novartis announced that the European Commission has approved Kymriah for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia.
Kymriah, the first CAR-T cell therapy ever approved by the U.S. FDA, 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 therapy to receive regulatory approval in the EU for these two distinct B-cell malignancies.
Novartis expects to launch initially for pediatric indications, as the drugmaker continues to ramp up capacity. Novartis has been actively pursuing options to expand manufacturing capabilities beyond its facility in Morris Plains, New Jersey. This includes our agreement with France-based CDMO, CELLforCURE.
Read the press release