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

First of Multiple Planned Global Submissions for Lifileucel in 2024 and 2025

Key Step in Global Expansion to Address >20,000 Patients Annually with Previously Treated Advanced Melanoma

SAN CARLOS, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapies for patients with cancer, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, a TIL cell therapy, for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. If approved, lifileucel will be the first and only approved therapy in this treatment setting in all European Union (EU) member states.

Raj K. Puri, M.D., Ph.D., Executive Vice President, Regulatory Strategy and Translational Medicine, stated, "This EU regulatory submission is the first step toward expanding lifileucel into global markets with a high prevalence of advanced melanoma. The unmet need and strength of the clinical data will support approval of lifileucel as the first and only approved therapy for advanced melanoma patients in the EU who have progressed following standard of care therapies. Following the accelerated approval in the U.S., our global expansion strategy can more than double the number of patients with significant unmet need who may access lifileucel."

The MAA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. If the MAA for lifileucel 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. Additional marketing submissions for lifileucel are on track in Canada and the United Kingdom during the second half of 2024 and in Australia in 2025. Each year, more than 20,000 people die from advanced melanoma in the U.S., EU, United Kingdom, Canada, and Australia.1

1. World Health Organization International Agency for Research on Cancer (IARC) GLOBOCAN 2022.

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.

Amtagvi™ and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks ofIovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.