Iovance Biotherapeutics (NASDAQ: IOVA) announced that Australia's Therapeutic Goods Administration granted conditional approval for Amtagvi (lifileucel) to treat previously treated advanced melanoma.

The therapy is indicated for adult patients with unresectable or metastatic melanoma who have been previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.

This marks the third marketing authorization for Amtagvi, following approvals in other markets. The tumor-derived autologous T cell immunotherapy represents the first T cell therapy for a solid tumor cancer approved in Australia and the first treatment option approved in the country for advanced melanoma after anti-PD-1 and targeted therapy.

Australia reports approximately 17,000 new melanoma cases diagnosed annually and more than 1,500 deaths each year, according to the press release. The company stated it is working to authorize its first Australian treatment center as part of its expansion strategy.

The TGA approval was 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. The Phase 2 study enrolled patients with metastatic melanoma who received lifileucel monotherapy.

Efficacy was established based on objective response rate and duration of response by Independent Review Committee per Response Evaluation Criteria in Solid Tumors version 1.1. The detailed results were published in the Journal for ImmunoTherapy of Cancer in 2022, with a five-year analysis published in the Journal of Clinical Oncology in 2025.

Iovance is currently investigating Amtagvi in frontline advanced melanoma in the Phase 3 TILVANCE-301 trial and in additional solid tumor types.