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TAMPA, Fla. — A first-of-its-kind cellular immunotherapy pioneered at Moffitt Cancer Center has received approval from the Food and Drug Administration and is now available for patients with advanced melanoma. Lifileucel is the first tumor-infiltrating lymphocyte therapy, or TIL, approved for solid tumors.

TIL therapy takes advantage of the immune system’s ability to seek out and fight cancer cells. Melanoma tumors are surgically removed and then sent to a manufacturing facility where the immune cells, known as tumor-infiltrating lymphocytes, are removed and grown to billions in number. To make room for the new army of immune cells, patients receive chemotherapy to temporarily deplete their immune system before receiving the one-time TIL infusion. The entire process takes about six to twelve weeks from surgery to infusion.

Results from a phase 2 clinical trial led by Moffitt surgical oncologist Amod Sarnaik, M.D., show that lifileucel has an objective response rate of 36% in patients with heavily pre-treated metastatic melanoma. Responses were durable, with more than 41% of patients still responding more than 18 months after TIL infusion.

“The FDA approval of TIL therapy is a breakthrough, ushering in a new era of T-cell immunotherapies. We now have a therapy that uses a patient’s own immune cells to fight their cancer and provide long-lasting remission. We have treated patients who still have no evidence of disease over 10 years later,” Sarnaik said.

Tumor-infiltrating lymphocyte therapy has been around for decades. Pre-clinical studies evaluating its efficacy began in the early 1980s at the National Cancer Institute (NCI). James J. Mulé, IPh.D., a world-renowned immunologist and associate center director of Translational Science at Moffitt, brought TIL research to the cancer center in 2003. His science and expertise led to additional studies at Moffitt with immunologist Shari Pilon-Thomas, Ph.D., in 2009 and clinical trials with Sarnaik a few years later, making Moffitt one of the first centers outside of the NCI to treat patients with the investigational therapy.

Moffitt is also working on the next generation of TIL therapy. Researchers are investigating innovative ways to stimulate and improve TIL therapy growth and manufacturing and the best timing for the therapy to ensure optimal patient outcomes. Moffitt researchers are expanding this therapeutic approach to treat other solid tumor cancer types, such as lung, sarcoma, cervical and bladder.

“We’re just scratching the surface with T-cell therapy and cell therapy for advanced cancers. This initial approval will give encouragement to the whole field to continue to invest in T-cell therapeutics, including TIL therapy,” said Moffitt President & CEO Patrick Hwu, M.D. “Moffitt’s groundbreaking research into second and third generation TIL therapies will help even more patients with other cancer types.”

FDA Press Release:

Media Availability: Moffitt experts and patients are available for interviews; please contact Kim Polacek, 813-745-7408 and

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 56 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 9,000 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit, and follow the momentum on Facebook, Twitter, Instagram and YouTube