Novocure’s Optune Pax Receives Japan Approval for Locally Advanced Pancreatic Cancer
Novocure has announced that Japan’s Ministry of Health, Labour and Welfare has approved Optune Pax for the treatment of adult patients diagnosed with unresectable locally advanced pancreatic cancer, used concomitantly with gemcitabine and nab-paclitaxel. The approval follows U.S. FDA approval in February 2026 and CE Mark in June 2026, and was based on positive results from the Phase 3 PANOVA-3 trial.
Optune Pax is a portable medical device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that disrupt processes critical for cancer cell division and survival, resulting in cancer cell death without significantly affecting healthy cells. The PANOVA-3 trial evaluated TTFields therapy used concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma compared to chemotherapy alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields. In the trial, Optune Pax was well-tolerated and did not exacerbate chemotherapy-related systemic toxicity, with no new safety signals observed and serious adverse events comparable between study arms. Most Optune Pax-treated patients experienced expected device-related skin adverse events under the arrays, the majority of which were mild to moderate. Results were published in the Journal of Clinical Oncology.
According to the World Health Organization, pancreatic cancer is one of the most lethal cancers and the fourth most frequent cause of cancer death in Japan, with incidence and death rates increasing while other cancer rates remain stable or decline. Approximately 46,000 patients are diagnosed with pancreatic cancer each year in Japan, with a five-year relative survival rate of just 12%. TTFields are electric fields that exert physical forces to kill cancer cells through multiple mechanisms, and because cancer cells have different properties than healthy cells, the therapy does not significantly affect healthy tissue. This enables TTFields therapy to be added to other cancer treatment modalities across approved indications.
Makoto Ueno, MD, PhD, Director of the Department of Gastroenterology at Kanagawa Cancer Center in Yokohama, said the approval of Optune Pax provides a promising new treatment option for locally advanced pancreatic cancer, a disease with an urgent need for effective therapies. Ueno noted that in the Phase 3 PANOVA-3 trial, there was a statistically significant improvement in overall survival and pain progression was delayed, helping to preserve overall quality of life for people with this disease.
Hidehito Kotani, Senior Vice President and Head of Asia Pacific at Novocure, said the approval by the Ministry of Health, Labour and Welfare is an important milestone for the company in its efforts to improve outcomes for some of the most challenging and aggressive cancers, including advanced pancreatic cancer. Kotani noted that Optune Pax is a fundamentally different treatment for solid tumor cancers and that Novocure looks forward to bringing this option to healthcare providers and people living with locally advanced pancreatic cancer.
