Novartis has announced today that the European Commission has approved Kymriah (tisagenlecleucel) for the treatment of acute lymphoblastic leukemia in children and adults up to 25 years of age.. Kymriah is a treatment co-developed with the University of Pennsylvania, which focuses on potentiating CAR-T cells. It is the first-in-class therapy to be granted approval by FDA and EC. It is already on the US market at $475,000 per treatment. The company has not provided any detail about the price strategy to be adopted for Kymriah in Europe at the moment.
At the same time, Novartis has announced it plans to invest CHF90m (€78.8m) in a new manufacturing site in Switzerland for Kymriah, which will create 450 jobs and will join the Morris Plains facility in New Jersey, already working at full capacity. Finally, Novartis has announced it plans to expand its French site, managed by CellforCure.