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Orlando Health Helps Lead the Way in FDA Approval of Advanced Melanoma Treatment

February 22, 2024

Orlando, FL (February 22, 2024) – Physicians at Orlando Health who pioneered a breakthrough protocol using tumor-infiltrating lymphocytes (TIL) to treat aggressive, late-stage melanoma and other advanced cancers is now available for patients.

The groundbreaking treatment, now approved by the FDA, for patients with melanoma, is the result of a multi-center international clinical trial under the direction of principal investigator Sajeve Thomas, MD, a board-certified medical oncologist and hematologist with Orlando Health Cancer Institute.

Called AMTAGVI (lifileucel), this novel approach utilizes the patient’s own T-cells to combat the disease. “We isolate the cancer-specific T-cells from a resected tumor, expand and proliferate them, producing anywhere from one billion to 150 billion cells,” says Dr. Thomas, who specializes in the treatment of melanoma, sarcoma and gastrointestinal conditions. “We then infuse the T-cells back to the patient, combined with additional medications to re-energize these cytotoxic T-cells against the cancer. This is done in a single infusion during one hospital admission.”

When patients respond well to treatment, results can be dramatic, melting tumors in a matter of weeks with no further therapies. The clinical trials found tumors shrank or remained stable in about 31.5% of patients, with 43.5% of those patients continuing to have a good response 12 months after treatment.

Tumors can continue to regress, becoming non-existent in some patients, who remain progression-free months and even years after the initial treatment. Based on this success, researchers at Orlando Health continue to conduct trials expanding TIL therapy for frontline melanoma combined with checkpoint inhibitors, lung, cervical, and head/neck, and several other cancers. 

Orlando Health is the only location in Central Florida to provide cellular therapy using TIL.


About Orlando Health

Orlando Health is a $2.6 billion not-for-profit health care organization and a community-based network of physician practices, hospitals, and outpatient care centers throughout Central Florida. The organization is home to the area’s only Level One Trauma Centers for adults and pediatrics and is a statutory teaching hospital system that offers both specialty and community hospitals. More than 2,000 physicians have privileges at Orlando Health, which is also one of the area’s largest employers with more than 18,000 employees who serve nearly 2 million Central Florida residents and more than 4,500 international patients annually.  Additionally, Orlando Health provides more than $204 million in support of community health needs.  More information can be found at

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