---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-075997"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2024-06-28T23:59:59+00:00"
generated_at: "2026-06-01T00:30:32.046269+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-075997
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2024-06-28T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465924075997/0001104659-24-075997-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924075997/tm2418485d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-075997
- JSON: https://secwatch.observer/filing/0001104659-24-075997.json
- Plain text: https://secwatch.observer/filing/0001104659-24-075997.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.