Optune Pax Approved in Japan for Unresectable Locally Advanced Pancreatic Cancer – Novocure
Novocure announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Optune Pax for the treatment of adult patients diagnosed with unresectable locally advanced pancreatic cancer, concomitant with gemcitabine and nab-paclitaxel.
“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. In the Phase 3 PANOVA-3 trial for Optune Pax, 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.” – Makoto Ueno, MD, PhD, Director, Department of Gastroenterology, Kanagawa Cancer Center, Yokohama.
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 approval of Optune Pax by the Ministry of Health, Labour and Welfare is an important milestone for Novocure in our efforts to improve outcomes for some of the most challenging and aggressive cancers, including advanced pancreatic cancer. Optune Pax is a fundamentally different treatment for solid tumor cancers and we look forward to bringing this option to healthcare providers and people living with locally advanced pancreatic cancer.” – Hidehito Kotani, Senior Vice President, Head of Asia Pacific, Novocure.
The MHLW approval of Optune Pax was based on the positive results of the Phase 3 PANOVA-3 trial.
The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma, compared to gem/nab-pac alone. The trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival for patients treated with TTFields.
In PANOVA-3, Optune Pax was well-tolerated and did not exacerbate gem/nab-pac-related systemic toxicity, no new safety signals were observed, and serious adverse events (SAEs) were comparable between study arms. Most Optune Pax-treated patients experienced the expected device-related skin adverse events (AEs) under the arrays (76.3% of the Optune Pax-treated participants). The majority of these events were mild to moderate (Grade 1-2), with 21 (7.7%) experiencing a Grade ≥3 event.
The results from the Phase 3 PANOVA-3 trial were published in the Journal of Clinical Oncology, available online.
Optune Pax was approved by the U.S. Food and Drug Administration in February 2026 and received a CE Mark in June 2026.
