Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma – Iovance Biotherapeutics
Iovance Biotherapeutics Inc. announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy. Amtagvi is indicated for the treatment of adult patients with unresectable or metastatic melanoma that has progressed on or after at least one prior systemic therapy including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor, and who have no satisfactory alternative treatment options.
Market authorization in Canada under the NOC/c guidance was granted based on safety and efficacy results from the global, multicenter C-144-01 trial investigating Amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. The market authorization is conditional, pending the results of trials to confirm its clinical benefit.
C-144-01 is a global, multicenter Phase II study in which patients received treatment with lifileucel monotherapy. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation‑positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR), and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The detailed results of C-144-01 were published in the Journal for ImmunoTherapy of Cancer in 2022. A five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025.
“This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers,” said Dr. Frederick Vogt, Interim Chief Executive Officer and President of Iovance. “We expect to authorize our first Canadian treatment center within the next few months, and we continue to advance our ex-U.S. strategy for Amtagvi in additional markets.”
See citations- Chesney J, Lewis KD, Kluger H et al. Efficacy and safety of lifileucel, a one- time autologous tumor- infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C- 144- 01 study. J ImmunoTher Cancer 2022, 10: e005755. doi:10.1136/ jitc-2022-005755
- Medina T,, Chesney JA , Kluger H et al. Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study. J Clin Oncol. 2025 JCO-25-00765 DOI:10.1200/JCO-25-00765
