IOVA News & Events

Iovance Biotherapeutics announced that the Therapeutic Goods Administration of Australia has granted conditional approval of Amtagvi for previously treated advanced melanoma. Amtagvi is a tumor-derived autologous T-cell immunotherapy indicated for adult patients with unresectable or metastatic melanoma who have been previously treated with a PD-1 blocking antibody and other targeted therapies if applicable. The company noted the approval represents the first T-cell therapy approved for a solid tumor cancer, with the regulatory decision supported by results from its global C-144-01 clinical trial. "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. "We are in the process of authorizing our first Australian treatment center as we advance our expansion strategy for Amtagvi in additional markets with a high prevalence of advanced melanoma."

Iovance Biotherapeutics announced allowance to proceed from the FDA for the investigational new drug, or IND, application for a Phase 1/2 basket trial of IOV-5001, a next-generation interleukin-12 tethered TIL therapy. The Phase 1/2 trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.