Health Canada issued a Notice of Compliance with Conditions for the tumor-derived autologous T cell immunotherapy, indicated for 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. The market authorization was granted 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 where applicable. "This approval in Canada is our first marketing authorization outside the U.S. and marks a significant step forward for Iovance as we prepare to introduce Amtagvi in countries with a high prevalence of advanced melanoma and address substantial unmet needs in solid tumor cancers," said Frederick Vogt, Ph.D., J.D., Interim CEO and President of Iovance.