Iovance Submits MAA for Lifileucel Therapy

Iovance Biotherapeutics, Inc. has made significant strides in advancing its lifileucel therapy, as the company recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. If approved, lifileucel would be the first and only approved therapy in this treatment setting in all European Union (EU) member states.

The submission is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Additionally, the company is planning multiple global submissions for lifileucel in 2024 and 2025, with additional marketing submissions on track in Canada and the United Kingdom during the second half of 2024 and in Australia in 2025.

This move represents a key step in Iovance Biotherapeutics' global expansion strategy to address the significant unmet need in advanced melanoma, as more than 20,000 people die from the disease annually in the U.S., EU, United Kingdom, Canada, and Australia.

Raj K. Puri, M.D., Ph.D., Executive Vice President, Regulatory Strategy and Translational Medicine at Iovance Biotherapeutics, expressed confidence in the strength of the clinical data, stating that it will support the 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.

It is anticipated that the MAA for lifileucel will be validated in the third quarter of 2024, with the expectation that the Committee for Medicinal Products for Human Use (CHMP) will issue a scientific opinion for the European Commission to adopt in 2025.

This marks an important milestone for Iovance Biotherapeutics as it aims to be a global leader in innovating, developing, and delivering tumor-infiltrating lymphocyte (TIL) therapies for cancer patients. The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, to extend and improve the lives of patients with cancer. The market has reacted to these announcements by moving the company's shares -2.1% to a price of $7.84. For more information, read the company's full 8-K submission here.

The above analysis is intended for educational purposes only and was performed on the basis of publicly available data. It is not to be construed as a recommendation to buy or sell any security. Any buy, sell, or other recommendations mentioned in the article are direct quotations of consensus recommendations from the analysts covering the stock, and do not represent the opinions of Market Inference or its writers. Past performance, accounting data, and inferences about market position and corporate valuation are not reliable indicators of future price movements. Market Inference does not provide financial advice. Investors should conduct their own review and analysis of any company of interest before making an investment decision.