{"schema_version":"secwatch.filing_event.v1","accession":"0001645113-25-000037","form_type":"8-K","ticker":"NVCR","cik":"0001645113","company_name":"NovoCure Ltd","filed_at":"2025-09-15T23:59:59+00:00","discovered_at":"2026-05-14T18:02:44.549956+00:00","generated_at":"2026-05-17T06:38:19.788020+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Japan MHLW approves Novocure's Optune Lua for advanced NSCLC","bullets":["Japan MHLW approved Optune Lua for concurrent use with PD-1/PD-L1 inhibitors in advanced/recurrent NSCLC after platinum-based chemo.","Approval based on Phase 3 LUNAR trial: median OS 13.2 vs 9.9 months (3.3-month improvement, p=0.04).","In PD-1/PD-L1 subgroup, median OS 19.0 vs 10.8 months (8.2-month improvement, p=0.02).","Optune Lua is a wearable TTFields device; device-related AEs were mostly grade 1-2 skin reactions."],"urls":{"canonical":"https://secwatch.observer/filing/0001645113-25-000037","json":"https://secwatch.observer/filing/0001645113-25-000037.json","markdown":"https://secwatch.observer/filing/0001645113-25-000037.md","text":"https://secwatch.observer/filing/0001645113-25-000037.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645113/000164511325000037/0001645113-25-000037-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645113/000164511325000037/nvcr-20250915.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T06:38:19.788020+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}