U.S. Food and Drug Administration Approves Tisagenlecleucel For Relapsed/ Refractory Large B-cell Lymphoma

New York, NY (May 1, 2018) –The U.S. Food and Drug Administration (FDA) announced it has approved the use of the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel (KYMRIAH ®) for the treatment of large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. CAR T-cell therapies such as tisagenlecleucel are a form of immunotherapy that modify and enhance a patient’s T-cells to recognize and destroy antigens present on the surface of lymphoma cells, promoting the body’s own immune response to the blood cancer.

“Today’s approval represents a significant development for people with lymphoma,” said Meghan Gutierrez, Chief Executive Officer of the Lymphoma Research Foundation. “CAR T-cell therapy has the potential to change the way we think about treating cancer and we applaud the FDA, Novartis, and the physicians and patients whose participation in clinical trials helped make this advancement possible.”

Today marks the second indication for Novartis’ cell-based gene therapy, which had been approved by the FDA for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia in the relapsed or refractory setting in August 2017.

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