Iovance's Amtagvi® (lifileucel) Receives Health Canada Approval for Advanced Melanoma

Core Viewpoint - Iovance Biotherapeutics has received conditional approval from Health Canada for Amtagvi (lifileucel), marking it as the first T cell therapy for solid tumors and the first treatment option for advanced melanoma after prior therapies [1][2]. Company Overview - Iovance Biotherapeutics focuses on developing novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for cancer patients and aims to be a leader in this field [5]. - The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, to improve patient outcomes [5]. Product Details - Amtagvi is indicated for adult patients with unresectable or metastatic melanoma who have progressed after at least one prior systemic therapy, including a PD-1 blocking antibody and, if applicable, a BRAF inhibitor [1][2]. - The approval in Canada is based on the results from the global, multicenter C-144-01 trial, which demonstrated safety and efficacy in patients previously treated with anti-PD-1 therapy [2][3]. Clinical Trials - The C-144-01 trial is a Phase 2 study that enrolled patients with metastatic melanoma, establishing efficacy based on objective response rate (ORR) and duration of response (DOR) [3]. - Iovance is also investigating Amtagvi in frontline advanced melanoma through the Phase 3 trial TILVANCE-301 and in additional solid tumor types [4]. Market Strategy - The company plans to authorize its first Canadian treatment center within the next few months and is advancing its strategy for Amtagvi in other international markets [2].