Also known as: Amtagvi, AMTAGVI
Amtagvi (lifileucel) is a tumor-derived autologous T-cell immunotherapy approved via FDA accelerated pathway for previously treated unresectable or metastatic melanoma. It is the first FDA-approved cellular therapy for this advanced melanoma setting and is administered after lymphodepletion with IL-2 support. The treatment carries substantial safety warnings and requires specialized administration.
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
Artios added six senior leaders in 2026 as alnodesertib moved toward late-stage development and potential U.S. commercialization. The company is also running a Phase 2 study of ART6043.
Iovance reported real-world data suggesting Amtagvi may have a best in class profile in advanced melanoma. The company posted $263.5 million in annual sales after 2024 approval, while pursuing broader use and facing regulatory and logistics risks.
Iovance Biotherapeutics reported Q4 2025 revenue of $87 million, beating estimates, while receiving FDA fast-track designation for lifileucel in non-small cell lung cancer and reporting strong sarcoma trial data.
