Iovance Biotherapeutics has received a long-awaited go-ahead from the US Food and Drug Administration for its tumor-infiltrating lymphocyte (TIL) cancer therapy. The approval for Amtagvi (lifileucel) for treating patients with unresectable or metastatic melanoma is a milestone: it marks the first immune cell therapy approved for solid tumors, and it is also the first made from TILs.

Amtagvi is a living therapy. It involves harvesting T cells from within a patient’s tumors, expanding them in bioreactors and reinfusing them. Those T cells seek out and recognize cancer neoantigens and, when re-infused, react to these antigenic epitopes and destroy the cancer cells. Steven Rosenberg, a surgeon at the US National Cancer Institute, first began treating patients with melanoma with TILs in 1988, later licensing the technology to Iovance.

Iovance Biotherapeutics 的肿瘤浸润淋巴细胞 (TIL) 癌症疗法获得了美国食品和药物管理局期待已久的批准。Amtagvi (lifileucel) 获批用于治疗不可切除或转移性黑色素瘤患者是一个里程碑：它标志着第一个获批用于实体瘤的免疫细胞疗法，也是第一个由 TIL 制成的免疫细胞疗法。

Amtagvi 是一种活体疗法。它涉及从患者肿瘤内采集 T 细胞，在生物反应器中扩增它们并重新注入它们。这些 T 细胞寻找并识别癌症新抗原，并在重新输注时对这些抗原表位发生反应并摧毁癌细胞。美国国家癌症研究所的外科医生 Steven Rosenberg 于 1988 年首次开始使用 TIL 治疗黑色素瘤患者，后来将该技术授权给 Iovance。