Iovance Biotherapeutics, Inc. (IOVA), announced that Australia's Therapeutic Goods Administration has granted conditional approval for Amtagvi (lifileucel), a tumor-derived autologous T cell immunotherapy, for adult patients with advanced melanoma who have previously received anti-PD-1 therapy and, if BRAF V600 mutation positive, targeted therapy.
Melanoma is a major health challenge in Australia, which has the highest incidence globally, with an estimated 17,000 new cases and more than 1,500 deaths annually. Amtagvi represents the first T cell therapy approved for a solid tumor cancer in the country and provides a new treatment option for patients with unresectable or metastatic melanoma after standard therapies.
Amtagvi was first approved by the U.S. FDA in February 2024 for advanced melanoma, marking the first FDA approval of a tumor-infiltrating lymphocyte therapy. Since the launch, U.S Amtagvi revenue has reached approximately $60 million. For the second quarter of 2026, Iovance has guided total product revenue of $86 million to $88 million, compared with $54.1 million in U.S. Amtagvi revenue in Q2 2025, with U.S. Amtagvi revenue expected at $79 million to $81 million, reflecting an anticipated approximately 23% increase from $65 million over the fourth quarter of 2025. Full year 2026 product revenue guidance stands at $350 million to $370 million compared to $264 million from full year 2025.
The Australian approval was supported by data from the global, multicenter C-144-01 study, which evaluated Amtagvi monotherapy in patients with advanced melanoma. Efficacy was measured by objective response rate and duration of response, with results published in the Journal for ImmunoTherapy of Cancer in 2022 and a five-year analysis in the Journal of Clinical Oncology in 2025.
"This approval in Australia is our third marketing authorization for Amtagvi and marks a significant step forward for Iovance in the country with the highest rate of melanoma globally," said Frederick Vogt Interim CEO and President of Iovance. The company is preparing to authorize its first Australian treatment center as part of its expansion strategy.Iovance continues to advance Amtagvi in additional indications, including a Phase 3 trial in frontline advanced melanoma (TILVANCE-301), and is exploring its tumor infiltrating lymphocyte (TIL) platform across multiple solid tumors.
IOVA has traded between $1.66 and $5.63 over the past year. The stock closed Wednesday's trading at $3.79, down 7.56%. During overnight trading the stock is at $3.80, up 0.26%.
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