---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-100996"
form_type: "8-K"
ticker: "IOVA"
cik: "0001425205"
company_name: "IOVANCE BIOTHERAPEUTICS, INC."
filed_at: "2023-09-15T23:59:59+00:00"
generated_at: "2026-06-10T16:10:19.901357+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA extends PDUFA date for Iovance's lifileucel BLA to Feb 24, 2024 due to resource constraints

## Summary
- FDA extended PDUFA target action date for lifileucel BLA from prior to February 24, 2024, citing resource constraints.
- No major review issues; all pre-approval inspections of clinical sites and manufacturing facilities completed successfully.
- No advisory committee meeting planned; Priority Review and RMAT designation remain intact.
- FDA agreed to work with Iovance to expedite remaining review, potentially allowing earlier approval.
- Lifileucel seeks accelerated approval for advanced melanoma with no currently FDA approved therapies in that setting.

## SEC filing metadata
- accession: 0001104659-23-100996
- form_type: 8-K
- ticker: IOVA
- cik: 0001425205
- company_name: IOVANCE BIOTHERAPEUTICS, INC.
- filed_at: 2023-09-15T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1425205/000110465923100996/0001104659-23-100996-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1425205/000110465923100996/tm2326192d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-100996
- JSON: https://secwatch.observer/filing/0001104659-23-100996.json
- Plain text: https://secwatch.observer/filing/0001104659-23-100996.txt

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