NovoCure Limited (Nasdaq: NVCR) announced on October 1, 2026, that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Optune Pax for the treatment of adult patients with unresectable locally advanced pancreatic cancer. The approval allows for the use of the device in conjunction with gemcitabine and nab-paclitaxel.
The regulatory decision was based on the results of the Phase 3 PANOVA-3 clinical trial. According to the filing, the trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with the therapy compared to chemotherapy alone.
NovoCure reports that the treatment was well-tolerated during the trial. The most common adverse events were device-related skin reactions occurring under the arrays, which affected 76.3% of participants. The company notes that the majority of these events were mild to moderate, with 21 patients, or 7.7% of the treated group, experiencing a Grade 3 or higher event.
The approval follows previous regulatory milestones for the product, including clearance from the U.S. Food and Drug Administration in February 2026 and a CE Mark in June 2026. The filing highlights the prevalence of pancreatic cancer in Japan, citing World Health Organization data that estimates approximately 46,000 patients are diagnosed with the disease annually in the country.
