Kymriah was the first CAR-T cell therapy approved by the U.S. FDA.
The FDA approved Kymriah, also called tisagenlecleucel, in August 2017 for certain children and young adults with B-cell acute lymphoblastic leukemia. It is made by removing a patient’s T cells, genetically modifying them to recognize the CD19 protein, and returning them to the patient.
CAR-T therapy is a form of personalized immunotherapy rather than a conventional drug or vaccine. Its approval marked a major breakthrough because a patient’s own immune cells were reprogrammed to attack cancer.
Yescarta followed later in 2017, so it was not the first FDA-approved CAR-T treatment. Kymriah’s original approval was for relapsed or refractory disease, not every type of leukemia or cancer.