[medical citation needed] The platform invented at the University of Pennsylvania was clinically developed by Novartis, including market authorization, and real world evidence.
[15] The treatment was developed by a group headed by Carl H. June and co-invented by Michael C. Milone[16] at the University of Pennsylvania, and is licensed to Novartis.
[17] In April 2017, tisagenlecleucel received breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed or refractory diffuse large B-cell lymphoma.
[18] In July 2017, an FDA advisory committee unanimously recommended that the agency approve it to treat B cell acute lymphoblastic leukemia that did not respond adequately to other treatments or have relapsed.
[24] In May 2018, the FDA further approved tisagenlecleucel to treat adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), based on results from the JULIET phase II trial.
[26] In March 2019, NICE issued guidance approving Kymriah for treatment of relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies.