Novocure (Nasdaq: NVCR) announced today 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,” said Makoto Ueno, MD, PhD, Director, Department of Gastroenterology, Kanagawa Cancer Center, Yokohama. “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.”

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,” said Hidehito Kotani, Senior Vice President, Head of Asia Pacific, Novocure. “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.”

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 at https://ascopubs.org/doi/10.1200/JCO-25-00746.

Optune Pax was approved by the U.S. Food and Drug Administration in February 2026 and received a CE Mark in June 2026.

Pancreatic Cancer

According to the World Health Organization (WHO), pancreatic cancer is one of the most lethal cancers and is the fourth most frequent cause of death from cancer in Japan.¹ While overall cancer incidence and death rates are remaining stable or declining, the incidence and death rates for pancreatic cancer are increasing.² It is estimated that in Japan approximately 46,000 patients are diagnosed with pancreatic cancer each year,³ with a five-year relative survival rate of just 12%.⁴

Physicians use different combinations of surgery, radiation, and pharmacological therapies to treat pancreatic cancer, depending on the stage of the disease. Unfortunately, most locally advanced pancreatic cancer cases are diagnosed when the cancer is no longer operable, meaning encasement of blood vessels, but no extra-pancreatic disease, leaving few treatment options. The standard of care for locally advanced pancreatic cancer is chemotherapy with or without radiation, and surgery if it is possible.

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multi-mechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and it demonstrated enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit novocure.com/ttfields.

About Novocure

Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.

Novocure’s global headquarters is located in Baar, Switzerland, with U.S. headquarters located in Portsmouth, New Hampshire and research and development facilities located in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and X.

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