{"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","discovered_at":"2026-10-01T13:02:00.290779+00:00","generated_at":"2026-10-12T14:18:12.366415+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Novocure's Optune Pax wins Japan MHLW approval for unresectable locally advanced pancreatic cancer","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001645113-26-000071","json":"https://secwatch.observer/filing/0001645113-26-000071.json","markdown":"https://secwatch.observer/filing/0001645113-26-000071.md","text":"https://secwatch.observer/filing/0001645113-26-000071.txt","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"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:18:12.366415+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"}