Amtagvi® (lifileucel) T-Cell Therapy

Melanoma is a life-threatening cancer once it advances beyond the possibility of surgical removal. In this case study, advanced melanoma refers to unresectable or metastatic disease. Immune checkpoint inhibitors and targeted BRAF and MEK therapies have transformed care for many patients with unresectable or metastatic disease, yet a substantial proportion never respond or ultimately progress, leaving limited options after standard therapy. This persistent gap has spurred efforts to harness the patient’s own immune system to control solid tumors.

Amtagvi^® (lifileucel) is a tumor-derived autologous T-cell therapy, also known as tumor-infiltrating lymphocyte (TIL) therapy, created from each patient’s resected tumor, expanded ex vivo, and administered as a single, individualized infusion. Over more than three decades, NCI’s Surgery Branch led by surgeon-scientist Steven Rosenberg pioneered and refined tumor-infiltrating lymphocyte (TIL) therapy. In the late 1980s his team showed that TILs harvested from a patient’s tumor and expanded with interleukin-2 could shrink metastatic melanoma. NCI investigators then improved the approach by optimizing manufacturing and adding lymphodepleting chemotherapy, establishing the clinical blueprint that ultimately enabled lifileucel.

To accelerate translation, NCI entered a Cooperative Research and Development Agreement with Lion Biotechnologies in 2011 (later Iovance Biotherapeutics), enabling protocol and process transfer for multicenter trials. NIH granted an exclusive patent license in 2015, with later updates expanding rights and non-exclusive access aligned with public health goals.

As the program matured, NIH and Iovance updated the licensing structure to balance broad public health access with continued innovation. In 2021 the parties executed an Amended and Restated NIH patent license that added rights and expanded non-exclusive access. In 2022 a Second Amended and Restated license added further exclusive rights and additional non-exclusive rights tied to TIL engineering and potency.

On February 16, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Amtagvi^® for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor. This decision marked the first FDA approval of a cellular therapy for a solid tumor; Amtagvi^® is also the first and only FDA-approved one-time T-cell therapy for previously treated melanoma.

FDA authorization and commercial availability in 2024 reflect decades of progress in adoptive cell transfer and the translation of that science into a scalable therapy by Iovance Biotherapeutics.

You can learn more about Amtagvi^®  through a recently published case study. 

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