Iovance Applies for EMA Approval for Lifileucel in Advanced Melanoma

Iovance Biotherapeutics, Inc., a biotechnology company specializing in innovative cell therapies for cancer treatment, has taken a significant step in its global expansion efforts. The company submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its TIL cell therapy, li, targeted at adult patients with unresectable or metastatic melanoma who have previously received treatment with a PD-1 blocking antibody and, if applicable, a BRAF inhibitor with or without a MEK inhibitor. Should this application be approved, li would become the first and only therapy available for this treatment setting across all European Union (EU) member states.

Dr. Raj K. Puri, Executive Vice President of Regulatory Strategy and Translational Medicine at Iovance Biotherapeutics, highlighted the importance of this submission as the first step in expanding li into international markets that have a high incidence of advanced melanoma. He underscored the unmet medical need and the robust clinical data that support the approval of li, making it the first approved therapy for advanced melanoma patients in the EU who have not responded to standard care therapies. This move follows the recent accelerated approval of li in the United States and is part of a strategy that could significantly increase the number of patients with access to this novel therapy.

The application to the EMA is bolstered by positive clinical data from the C-144-01 clinical trial involving advanced post-anti-PD1 melanoma patients. If the MAA is validated, which is anticipated in the third quarter of 2024, the Committee for Medicinal Products for Human Use (CHMP) is expected to issue a scientific opinion for the European Commission to adopt in 2025. Moreover, Iovance has planned additional marketing submissions for li in Canada and the United Kingdom later in 2024, and in Australia in 2025. Annually, advanced melanoma claims the lives of over 20,000 people across the U.S., EU, United Kingdom, Canada, and Australia.

Iovance is dedicated to becoming a global leader in the development and delivery of TIL therapies for cancer patients. The company's innovative approach harnesses the human immune system's ability to identify and eliminate diverse cancer cells in individual patients. Their TIL platform has showcased promising clinical outcomes in various solid tumors, and their product, Amtagvi™, is the first FDA-approved T cell therapy for a solid tumor indication. Iovance continues to innovate in cell therapy, including gene-edited cell therapy, with the goal of extending and improving the lives of cancer patients.

Amtagvi™ and Proleukin®, along with other trademarks, are the property of Iovance Biotherapeutics, Inc. The company remains committed to continuous advancements in cell therapy, striving to address significant unmet medical needs in the oncology sector.

This latest development signifies a promising advancement in the fight against advanced melanoma, potentially offering new hope for thousands of patients who have limited treatment options following standard therapies.