Novartis in outcomes deal with CMS as CAR T approved

FDA approved the first chimeric antigen receptor T cell (CAR T) therapy, Kymriah tisagenlecleucel-T from Novartis AG (NYSE:NVS; SIX:NOVN), and the pharma simultaneously announced a $475,000 price for the therapy as well as an outcomes-based arrangement with the U.S. Centers for Medicare & Medicaid Services (CMS).

The agency approved Kymriah (formerly CTL019) to treat patients up to 25 years old with B cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. The approval was based on the pivotal Phase II ELIANA trial in which Kymriah met the primary endpoint with an overall remission rate of 82.5% in 63 ALL patients, with 75% of patients still in remission at six months...