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

NovoCure Ltd

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.

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