Iovance Biotherapeutics Submits Marketing Authorization Application to European Medicines Agency for Lifileucel in Advanced Melanoma

Core Viewpoint - Iovance Biotherapeutics, Inc. has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy aimed at treating adult patients with unresectable or metastatic melanoma previously treated with PD-1 blocking antibodies [1][4] Group 1: Company Developments - The MAA submission for lifileucel is backed by positive clinical data from the C-144-01 clinical trial involving patients with advanced post-anti-PD1 melanoma [4] - If validated, the MAA is expected to receive a scientific opinion from the Committee for Medicinal Products for Human Use (CHMP) in the third quarter of 2024, with potential adoption by the European Commission in 2025 [4] - Additional marketing submissions for lifileucel are planned for Canada and the United Kingdom in the second half of 2024, and for Australia in 2025 [4] Group 2: Market Opportunity - Each year, over 20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia, indicating a significant unmet medical need [4] - The submission of lifileucel represents a strategic step in addressing this unmet need and expanding the company's market presence in regions with high prevalence of advanced melanoma [7] Group 3: Innovation and Strategy - Iovance Biotherapeutics aims to be a global leader in TIL therapies, focusing on harnessing the human immune system to target diverse cancer cells [4] - The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, to improve patient outcomes [4]