---
schema_version: "secwatch.filing_event.v1"
accession: "0001645113-24-000005"
form_type: "8-K"
ticker: "NVCR"
cik: "0001645113"
company_name: "NovoCure Ltd"
filed_at: "2024-01-18T23:59:59+00:00"
generated_at: "2026-06-06T21:57:57.571462+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA accepts Novocure's PMA for TTFields in NSCLC post-platinum; decision H2 2024

## Summary
- PMA application accepted for filing; FDA begins substantive review.
- Submission filed Dec 15, 2023; regulatory decision expected in second half 2024.
- TTFields therapy plus standard systemic therapies for NSCLC after progression on platinum-based therapy.
- CEO states milestone brings therapy closer to patients with few non-toxic options.
- Application based on LUNAR trial data in post-platinum NSCLC.

## SEC filing metadata
- accession: 0001645113-24-000005
- form_type: 8-K
- ticker: NVCR
- cik: 0001645113
- company_name: NovoCure Ltd
- filed_at: 2024-01-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1645113/000164511324000005/0001645113-24-000005-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645113/000164511324000005/nvcr-20240118.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001645113-24-000005
- JSON: https://secwatch.observer/filing/0001645113-24-000005.json
- Plain text: https://secwatch.observer/filing/0001645113-24-000005.txt

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