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Moffitt Treats First U.S. Patient with Newly FDA-Approved CAR T Therapy

December 07, 2017

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Moffitt Cancer Center has treated the first U.S. adult lymphoma patient with a therapy formerly available only through clinical trials. The therapy, called Yescarta™, was recently approved by the Food and Drug Administration for patients with an aggressive form of non-Hodgkin lymphoma called diffuse large B cell lymphoma. Moffitt co-led the clinical trials preceding Yescarta’s FDA approval. By early December, another 10 patients were awaiting treatment at Moffitt now that the therapy is commercially available.

"We are proud to lead worldwide efforts in this next phase of CAR T treatment for lymphoma patients and bring this critical innovation to as many patients as possible," said Frederick Locke, M.D., vice chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy at Moffitt. "The clinical trials showed us the incredible results this treatment can have for patients; we expect many lives will be extended as commercial opportunity expands first from the United States, to other countries around the world."

Yescarta, the first CAR T therapy approved by the FDA for adult lymphoma, is for patients whose cancer has failed two lines of chemotherapy. CAR T is a personalized therapy using a patient’s own immune system T cells to fight cancer. For this treatment, a patient’s T cells are gathered from the blood and engineered with additional receptors to help identify, attack and ultimately destroy the cancer cells. The re-engineered T cells are then given back to the patient much like a blood transfusion, in a single treatment. They enable the body’s immune system to better combat the disease.

Moffitt co-led the ZUMA-1 national clinical trial, serving as the first cancer center to treat patients in the investigational setting. Moffitt provided the first commercial infusion to a patient on Nov. 27 at the hospital’s main campus in Tampa. Of the Moffitt patients currently enrolled, one has received the CAR T infusion, six have undergone the initial T cell removal process known as apheresis, and four are scheduled for T cell removal in the next few weeks.

Yescarta, which is manufactured by Kite, a Gilead Company, received FDA approval on Oct. 18.

If you’d like to learn more about CAR T therapy, call 1-888-663-3488 or complete a new patient registration form online to request an appointment. No referrals are necessary.