Iovance’s Amtagvi wins Canadian approval in advanced melanoma

Health Canada has approved Iovance Biotherapeutics’ Amtagvi, a tumor-derived autologous T cell immunotherapy, for advanced melanoma.

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 phase 2 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.

The Canadian approval is Iovance’s first marketing authorization outside the U.S. and the first treatment option approved in Canada for advanced melanoma after anti-PD-1 and targeted therapy. The therapy was granted FDA accelerated approval for the same indication in February 2024.

The proposed mechanism for Amtagvi offers a new cell therapy approach that deploys patient-specific T cells called TIL cells. When cancer is detected, the immune system creates TIL cells to locate, attack and destroy cancer. When cancer prevails, the body’s natural TIL cells can no longer perform their intended function to fight cancer. Amtagvi is manufactured using a proprietary process to collect and expand a patient’s unique T cells from a portion of their tumor. The treatment, delivered as an intravenous infusion, returns billions of the patient’s T cells back to the body to fight their cancer.