Iovance's Amtagvi granted TGA approval in Australia for advanced melanoma

IOVANCE BIOTHERAPEUTICS, INC.

• Therapeutic Goods Administration of Australia approved Amtagvi for previously treated advanced melanoma.
• Indicated for patients who received anti-PD-1 therapy and, if BRAF V600+, a BRAF/MEK inhibitor.
• Third marketing authorization for Amtagvi; Iovance is authorizing its first Australian treatment center.
• Australia has the world's highest melanoma rate, with ~17,000 new cases annually.
• Approval based on Phase 2 C-144-01 trial results showing objective response rate and duration of response.