FDA Approves CAR T-Cell Therapy for Non-Hodgkin Lymphoma

Dana-Farber/Brigham and Women’s Cancer is one of few centers in the country certified to offer this new approach.

Following a successful clinical trial involving Dana-Farber Cancer Institute and Brigham and Women’s Hospital, the first chimeric antigen receptor (CAR) T-cell therapy for adult cancers was approved by the Food and Drug Administration (FDA) on Oct.19. Dana-Farber/Brigham and Women’s Cancer Center was the only facility in the northeast to be part of the clinical trial that led to FDA approval and is one of a few locations certified to offer this new therapy nationwide.

The drug, known as Yescarta (axicabtagene ciloleucel), was developed by Kite Pharma and can now be used to treat adults with relapsed or refractory aggressive B cell non-Hodgkin lymphoma (NHL). The FDA ruling is based on the results of a clinical trial that showed the therapy to be safe and effective. On this nationwide trial, 101 patients received Yescarta and 82 percent of patients responded to the treatment, with 54 percent of patients having a complete response to therapy, according to results presented in June at the Lugano International Conference on Malignant Lymphoma.

“The successful development of CAR T-cells as a therapy for cancer, on the heels of the success of immune checkpoint blockade drugs, is a testament to the progress we have made in understanding how our immune system is regulated and how cancer evades the immune system,” said Caron A. Jacobson, MD, Medical Director of the Immune Effector Cell Therapy program at Dana-Farber/Brigham and Women’s Cancer Center. “It is a perfect example of how basic science research can fuel clinical progress. Now we need to take what we can from the clinic back to the laboratory to make this therapy even better.”

The initial clinical trials of CAR T-cell therapy have involved pediatric and adult patients with blood-based cancers such as leukemia, lymphoma, and multiple myeloma. Based on the therapy’s success so far, CAR T-cell therapy trials are now opening for certain types of solid tumors as well.

For more information, call 877-801-2278 or visit dana-farber.org/lymphomacart.

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