---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-025082"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2024-02-20T23:59:59+00:00"
generated_at: "2026-06-05T22:57:17.970314+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-025082
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2024-02-20T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 2.02, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465924025082/0001104659-24-025082-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465924025082/tm246580d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-025082
- JSON: https://secwatch.observer/filing/0001104659-24-025082.json
- Plain text: https://secwatch.observer/filing/0001104659-24-025082.txt

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