Photo credit of Dana-Farber Cancer Institute and Sam Ogden.
Following a successful clinical trial involving Dana-Farber Cancer Institute, the first chimeric antigen receptor (CAR) T-cell therapy for adult cancers was approved by the Food and Drug Administration (FDA) on Oct. 18. The only facility in the northeast to be part of the clinical trial, Dana-Farber is one of a few locations certified to offer this new therapy nationwide, and the only one in New England.
The drug, known as Yescarta (axicabtagene ciloleucel), can now be used to treat adults with refractory aggressive B cell non-Hodgkin lymphoma. The FDA ruling is based on the results of a nationwide trial in which 82 percent of patients responded to the treatment, with 54 percent of patients having a complete response to therapy. Thirty-six percent of patients remain in complete remission six months after treatment.
CAR T-cell therapy, like all forms of cancer immunotherapy, seeks to sharpen and strengthen the immune system’s inherent cancer-fighting powers. To convert normal T-cells into CAR T-cells, technicians first extract T-cells from a patient’s blood and genetically engineer them in a lab to produce proteins on their surface called chimeric antigen receptors, or CARs. The CARs serve a dual purpose: to enable the T-cells to latch onto specific tumor cell proteins called antigens, and to signal the T-cells to kill those tumor cells. The newly minted CAR T-cells grow in a lab until they number in the hundreds of millions, and are then infused into the patient. If successful, the CAR T-cells will continue to reproduce in the patient’s body, and serve as an effective fighting force against cancer cells.
“It is extremely rewarding to be able to offer a new therapy to patients who had virtually no other options just 12 to 24 months ago,” says Caron A. Jacobson, MD, medical director of the Immune Effector Cell Therapy program at Dana-Farber, who has been testing Yescarta in a clinical trial. “This therapy requires just a one-time infusion for patients, and the results are evident within one month. It is our goal as clinicians to help patients and improve their quality of life. Seeing these patients return to work, their families, and their livelihoods so quickly is an important reminder of how far we have come. It is also inspiration for the work we still need to do.”
The approval follows the FDA’s recent first-ever approval of CAR T-cell therapy for the treatment of some pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) in August, which will also be offered at Dana-Farber.