Amtagvi, First FDA-Approved Cell Therapy for Solid-Tumor Cancers, Available at Roswell Park

BUFFALO, N.Y. — Expanding access to a breakthrough treatment option for patients with metastatic melanoma, Roswell Park Comprehensive Cancer Center has been approved to administer the newly FDA-approved tumor-infiltrating lymphocyte (TIL) therapy Amtagvi. This “living drug” cell therapy is manufactured by Iovance Biotherapeutics.  

Amtagvi, also known as lifileucel, is a form of adoptive cell therapy that uses a patient’s own cells to treat cancer. TIL therapy takes T cells from the patient’s tumor, activates and multiplies them into billions of cells in a lab, and returns the T cells to the patient. While similar to other cellular therapies such as stem cell/bone marrow transplant or chimeric antigen receptor T-cell therapy, TIL therapy is the first cell therapy approved to treat solid-tumor cancers. 

Melanoma accounts for only 5 percent of all skin cancers but it is the most serious skin cancer type and is more likely than other skin cancers to spread to lymph nodes and other parts of the body. This therapy is approved for a small group of melanoma patients — those whose disease has not responded to other therapies.

Roswell Park helped pave the way for FDA approval by conducting a pivotal clinical trial of the TIL therapy, giving patients early access to the treatment. In the multisite trial, lifileucel was found to attack patients’ melanoma cells, reduce the size of tumors and produce a lasting response. Of all patients with complete or partial response many were still responding to therapy after more than 2 years. 

Dr. Igor Puzanov

“This TIL therapy offers an important option for patients with advanced melanoma that has proven quite challenging,” says Igor Puzanov, MD, MSCI, FACP, Chief of Melanoma at Roswell Park and who led the onsite clinical trial, “We are thrilled that we can offer this treatment to our patients. We look to the future of TIL therapy as we know other cancers are close behind.”

Dr. Puzanov, who is also Director of the Center for Early Phase Clinical Trials, notes that studies of lifileucel in patients with cervical cancer and non-small cell lung cancer (NSCLC) are ongoing at Roswell Park with an additional trial for young adult patients with sarcoma expected to open soon. 

Roswell Park is one of about two dozen centers across the nation authorized to treat patients with lifileucel (Amtagvi). For more information about Amtagvi and TIL therapy, call 1-800-ROSWELL (1-800-767-9355). 

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From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.