Iovance receives FDA accelerated approval for AMTAGVI (lifileucel) in advanced melanoma

IOVANCE BIOTHERAPEUTICS, INC.

AMTAGVI is first FDA-approved T cell therapy for a solid tumor cancer, indicated for advanced melanoma after anti-PD-1 and BRAF/MEK therapy.
Pivotal cohort (n=73) showed 31.5% objective response rate; median duration of response not reached at 18.6 months follow-up.
Preliminary cash, equivalents, investments, and restricted cash of $346.3M as of Dec 31, 2023, including $114.9M cash and equivalents.
Iovance Cell Therapy Center in Philadelphia has capacity for several thousand patients annually; 30+ authorized treatment centers prepared.
Phase 3 confirmatory trial TILVANCE-301 ongoing; boxed warning includes treatment-related mortality and severe cytopenia.

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