Iovance submits MAA to EMA for lifileucel in advanced melanoma; first of multiple global filings

IOVANCE BIOTHERAPEUTICS, INC.

MAA seeks approval for lifileucel after prior PD-1 and BRAF/MEK therapy; would be first approved TIL therapy in EU.
Submission supported by Phase 2 C-144-01 trial data; validation expected Q3 2024; CHMP opinion in 2025.
Additional marketing submissions planned in Canada and UK in H2 2024, and Australia in 2025.
Targets >20,000 patients annually in U.S., EU, UK, Canada, and Australia with advanced melanoma.
EU expansion follows U.S. accelerated approval of lifileucel (Amtagvi) in February 2024.

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