---
schema_version: "secwatch.filing_event.v1"
accession: "0001645113-26-000085"
form_type: "8-K"
ticker: "NVCR"
cik: "0001645113"
company_name: "NovoCure Ltd"
filed_at: "2026-11-09T11:59:49+00:00"
generated_at: "2026-11-09T12:05:52.397086+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues Not Approvable Letter for Novocure's Optune Mya PMA in NSCLC brain metastases

## Summary
- FDA determined uncertainty around degree of clinical benefit of Optune Mya prevented approval; no safety concerns were raised.
- Optune Mya sought approval for adult patients with brain metastases from non-small cell lung cancer following stereotactic radiation.
- Novocure plans to meet with the FDA to explore options for approval that would not require additional clinical studies.
- Company said there can be no assurance that discussions or future submissions will lead to approval; announced November 9, 2026.

## SEC filing metadata
- accession: 0001645113-26-000085
- form_type: 8-K
- ticker: NVCR
- cik: 0001645113
- company_name: NovoCure Ltd
- filed_at: 2026-11-09T11:59:49+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1645113/000164511326000085/0001645113-26-000085-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1645113/000164511326000085/nvcr-20261109.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001645113-26-000085
- JSON: https://secwatch.observer/filing/0001645113-26-000085.json
- Plain text: https://secwatch.observer/filing/0001645113-26-000085.txt

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