Iovance Biotherapeutics, Inc., a leading biotechnology company specializing in novel tumor infiltrating lymphocyte (TIL) therapies, has announced a landmark achievement with the conditional approval of Amtagvi® (lifileucel) by Health Canada. This marks the first T-cell therapy for a solid tumor cancer to be approved in Canada and provides a crucial new treatment option for a specific population of patients with advanced melanoma.

Amtagvi® is indicated for adult patients with unresectable or metastatic melanoma who have exhausted other standard treatment options. This includes individuals whose cancer has progressed after receiving at least one prior systemic therapy, such as a PD-1 blocking antibody, and, for patients with the BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor. This approval addresses a significant unmet medical need for a patient group that has limited satisfactory treatment alternatives.

The market authorization was granted under Health Canada's Notice of Compliance with Conditions (NOC/c) guidance. This conditional approval is based on the robust safety and efficacy data from the global, multicenter Phase 2 C-144-01 trial. In this study, Amtagvi® demonstrated clinically meaningful activity, with detailed results published in the Journal for ImmunoTherapy of Cancer in 2022 and a five-year analysis published in the Journal of Clinical Oncology in 2025. The data showed durable responses and a promising five-year overall survival rate for heavily pretreated patients. The conditional nature of the approval means that Iovance will continue to provide data from ongoing trials to confirm the clinical benefit.

Amtagvi® is a tumor-derived autologous T-cell immunotherapy, leveraging a patient's own immune system to fight their cancer. The treatment involves a unique process: T-cells are harvested directly from a patient's tumor, multiplied to billions in a laboratory, and then re-infused into the patient. These Tumor-Infiltrating Lymphocytes (TILs) are already programmed to recognize the patient's specific cancer cells, making the therapy a highly personalized and targeted approach. Unlike other cell therapies that may target a single antigen, TIL therapy is polyclonal, meaning it can attack a wide variety of cancer antigens.

This Canadian approval is the first marketing authorization for Iovance outside the U.S., where Amtagvi® was the first FDA-approved T-cell therapy for a solid tumor indication. According to Iovance's Interim CEO, Frederick Vogt, this is a significant step in the company's global strategy to bring its innovative therapies to countries with a high prevalence of advanced melanoma. The company plans to authorize its first Canadian treatment center in the coming months, marking the official commercial launch of the therapy in the country. Iovance is also investigating Amtagvi® in a Phase 3 trial for frontline advanced melanoma and for other solid tumor types, with a mission to revolutionize cancer care by harnessing the body’s own immune system.