Kymriah gets second U.S. approval

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA approved CAR T therapy Kymriah tisagenlecleucel to treat adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after two or more lines of therapy.

FDA approved Kymriah in August 2017 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 agency's first for a CAR T therapy. Novartis struck an outcomes-based arrangement with CMS for Kymriah that allowed it to launch with a reimbursement code upon approval (see BioCentury, Sept. 1. 2017)...