New Treatment Option for Advanced Melanoma
Iovance Biotherapeutics' Amtagvi (lifileucel) has been approved by the Therapeutic Goods Administration (TGA) of Australia for the treatment of advanced melanoma, announced on 3rd June 2026.
Amtagvi is a tumor-derived autologous T cell immunotherapy, specifically indicated for adult patients with unresectable or metastatic melanoma who have previously been treated with a PD-1 blocking antibody. The approval also applies to those with a BRAF V600 mutation who have received a BRAF inhibitor, with or without a MEK inhibitor.
Interim CEO and President of Iovance, Frederick Vogt, Ph.D., J.D., expressed enthusiasm over the Australian approval, highlighting it as their third marketing authorisation for Amtagvi globally.
Clinical Trials and Approval Basis
The TGA's decision was based on results from the global, multicentre C-144-01 trial. This Phase 2 study assessed the safety and efficacy of lifileucel monotherapy in patients with advanced melanoma who had previously undergone systemic therapy, including a PD-1 blocking antibody and, if applicable, a BRAF inhibitor.
The C-144-01 trial demonstrated efficacy through objective response rate and duration of response metrics, reviewed by an Independent Review Committee. Detailed results were published in the Journal for ImmunoTherapy of Cancer in 2022, with a five-year analysis appearing in the Journal of Clinical Oncology in 2025.
Australia records approximately 17,000 new melanoma cases and over 1,500 deaths annually, highlighting the urgent need for new treatments. Amtagvi's introduction provides a critical option for patients with advanced melanoma.
Iovance is also conducting a Phase 3 trial, TILVANCE-301, to investigate Amtagvi in frontline advanced melanoma, as well as in other solid tumor types. This trial, registered under NCT05727904, aims to expand treatment possibilities.
Following the approval, the first Australian treatment centre is in the process of being authorised, paving the way for further expansions in regions with high melanoma prevalence.
Similar to the U.S. and other global markets, the need for innovative therapies is significant in Australia, given its high melanoma rates. Iovance's expansion strategy aims to address this demand by making Amtagvi widely available.
