regulatory
confidence high
sentiment positive
materiality 0.70
Iovance's Amtagvi receives Health Canada approval for advanced melanoma
IOVANCE BIOTHERAPEUTICS, INC.
- Health Canada issued NOC/c for Amtagvi (lifileucel) for unresectable/metastatic melanoma after anti-PD-1 and targeted therapy.
- First marketing authorization outside the U.S.; first T cell therapy approved for a solid tumor cancer in Canada.
- Approval based on Phase 2 C-144-01 trial ORR and DOR by IRC; results published in 2022 and 2025 journals.
- Iovance expects to authorize first Canadian treatment center within next few months; advancing ex-U.S. strategy.
- Amtagvi is also being investigated in frontline advanced melanoma (Phase 3 TILVANCE-301) and other solid tumors.