What type of drug is Kymriah (tisagenlecleucel)?

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy. In CAR-T cell therapy, a patient's cells are modified genetically to include a specific protein that directs the T-cells to target and kill leukemia cells that have a specific antigen (CD19) on the surface. T-cells are a type of white blood cell in the immune system.

What is Kymriah approved to treat?

• Kymriah is used in pediatric and young adult patients (up to age 25) with B-cell acute lymphoblastic leukemia (ALL) that has returned after prior treatments or has not responded to treatment (relapsed or refractory).
• It is also approved for patients with relapsed or refractory diffuse large B-cell lymphoma.
• In May 2022, the FDA approved Kymriah to treat adult patients with relapsed or refractory follicular lymphoma (FL).

Kymriah is not approved for treatment of patients with primary central nervous system lymphoma.

Kymriah is a genetically-modified autologous T-cell immunotherapy. The therapy is derived from a patient's own white blood cells through a process known as leukapheresis. Once the cells are modified, they are infused back into the patient to kill the cancer cells.

CAR-T cell therapy is a highly individualized and specialized treatment. You will receive your infusion in a certified healthcare center that may not be close to your home. You will be required to stay within a 2 hours drive of the center, usually for 30 days, to receive special treatment if needed and to monitor for side effects.

Which CAR-T cell therapies are approved?

Kymriah, approved in August 2017, was the first FDA-approved cell-based gene therapy in the U.S.

CAR-T cell therapies approved by the FDA include:

• Abecma (idecabtagene vicleucel)
• Breyanzi (lisocabtagene maraleucel)
• Carvykti (ciltacabtagene autoleucel)
• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Yescarta (axicabtagene ciloleucel)

Learn More: Car-T Cell Therapy: Top 10 Questions Answered

This is not all the information you need to know about Kymriah (tisagenlecleucel) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Kymriah information here, and discuss this information and any questions you have with your doctor or other health care provider.