What is the status of the marketing authorization application (MAA) for lifileucel in Canada?

Iovance Biotherapeutics is actively pursuing regulatory approvals to expand its commercial footprint, including in Canada. The company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for lifileucel, which is supported by positive clinical data from the C-144-01 clinical trial. If approved, lifileucel will be the first and only approved therapy in this treatment setting in the European Union (EU) and is expected to support approval as the first and only approved therapy for advanced melanoma patients in Canada who have progressed following standard of care therapies. The company is on track to submit additional marketing submissions for lifileucel in Canada and the United Kingdom during the second half of 2024, with plans to expand into Australia in 2025.