---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-129751"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2023-12-27T23:59:59+00:00"
generated_at: "2026-06-07T06:51:30.382173+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA places clinical hold on Iovance's LN-145 NSCLC trial after fatal adverse event

## Summary
- FDA placed clinical hold on IOV-LUN-202 on Dec 22, 2023, after a Grade 5 fatal SAE potentially linked to preconditioning.
- Enrollment paused; previously treated patients monitored; those with tumor resection continue with risk mitigations.
- No impact on other Iovance trials or lifileucel BLA; PDUFA date remains Feb 24, 2024.
- Updated Nov 2023 data: 71% of confirmed responders had duration of response >6 months.
- Iovance will work with FDA to resume enrollment safely.

## SEC filing metadata
- accession: 0001104659-23-129751
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2023-12-27T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- 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/1425205/000110465923129751/0001104659-23-129751-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465923129751/tm2333764d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-129751
- JSON: https://secwatch.observer/filing/0001104659-23-129751.json
- Plain text: https://secwatch.observer/filing/0001104659-23-129751.txt

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