---
schema_version: "secwatch.filing_event.v1"
accession: "0001645113-26-000071"
form_type: "8-K"
ticker: "NVCR"
cik: "0001645113"
company_name: "NovoCure Ltd"
filed_at: "2026-10-01T13:00:29+00:00"
generated_at: "2026-10-12T14:18:12.366415+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Novocure's Optune Pax wins Japan MHLW approval for unresectable locally advanced pancreatic cancer

## Summary
- Japan's MHLW approved Optune Pax for adults with unresectable locally advanced pancreatic cancer, given with gemcitabine and nab-paclitaxel.
- Approval based on Phase 3 PANOVA-3, which met its primary endpoint with statistically significant improvement in median overall survival vs chemo alone; pain progression delayed.
- No new safety signals; device-related skin adverse events under arrays in 76.3% of Optune Pax patients, mostly Grade 1-2, with 21 (7.7%) Grade 3 or higher.
- Optune Pax was FDA-approved in February 2026 and received CE Mark in June 2026; Japan sees ~46,000 pancreatic cancer diagnoses yearly with 12% five-year relative survival.
- Novocure cited Makoto Ueno of Kanagawa Cancer Center and Hidehito Kotani, SVP Head of Asia Pacific, in the October 1, 2026 announcement.

## SEC filing metadata
- accession: 0001645113-26-000071
- form_type: 8-K
- ticker: NVCR
- cik: 0001645113
- company_name: NovoCure Ltd
- filed_at: 2026-10-01T13:00:29+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/1645113/000164511326000071/0001645113-26-000071-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645113/000164511326000071/nvcr-20261001.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001645113-26-000071
- JSON: https://secwatch.observer/filing/0001645113-26-000071.json
- Plain text: https://secwatch.observer/filing/0001645113-26-000071.txt

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