Iovance Biotherapeutics, Inc. has announced that its tumor-derived autologous T cell immunotherapy, amtagvi® (lifileucel), has received approval from Health Canada for the treatment of adult patients with unresectable or metastatic melanoma. This marks the company's first marketing authorization outside the U.S. and represents a significant step forward as they prepare to introduce amtagvi in countries with a high prevalence of advanced melanoma.
The approval in Canada comes after the conditional market authorization was granted based on safety and efficacy results from the global, multicenter C-144-01 trial. This trial investigated amtagvi in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy. The detailed results of C-144-01 were published in the Journal for Immunotherapy of Cancer in 2022, and a five-year analysis was published in the Journal of Clinical Oncology in 2025.
It's worth noting that the market authorization is conditional, pending the results of trials to confirm its clinical benefit. Iovance is also investigating amtagvi in frontline advanced melanoma in the phase 3 trial, TILVANCE-301 (NCT05727904), as well as in additional solid tumor types.
Frederick Vogt, Ph.D., J.D., interim chief executive officer and president of Iovance, highlighted the significance of this approval, stating that it represents a substantial step forward for the company as they prepare to address substantial unmet needs in solid tumor cancers.
This approval is a significant milestone for Iovance Biotherapeutics, Inc. and provides a new treatment option for patients with advanced melanoma in Canada. The market has reacted to these announcements by moving the company's shares 4.0% to a price of $2.60. If you want to know more, read the company's complete 8-K report here.
