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May 7, 2018 – The U.S. Food and Drug Administration (FDA) granted tisagenlecleucel (Kymriah®), formerly known as CTL019, its second approval to treat patients with diffuse large B-cell lymphoma (DLBCL) whose cancer had worsened or returned despite two or more earlier treatments, or are ineligible for an autologous stem cell transplant (ASCT). Kymriah was approved in August 2017, by the FDA for patients 25 or younger with acute lymphoblastic leukemia, another type of blood cancer.
Kymriah is a one-time autologous T-cell immunotherapy treatment. Each dose of it is a customized treatment created using an individual patient’s own T-cells. The T-cells are collected and sent to a manufacturing center where they are altered to include a new gene that contains a CAR. The CAR will direct the T-cells to target and eliminate leukemia cells that have CD19, a specific antigen, on the surface. Once modified, the cells are infused back into the patient to kill the cancer cells.