Baar, Switzerland — February 11, 2026 — Leads & Copy — Novocure announced today that the U.S. Food and Drug Administration (FDA) has approved Optune Pax for treating adult patients with locally advanced pancreatic cancer, when used with gemcitabine and nab-paclitaxel.
The approval is based on the Phase 3 PANOVA-3 trial, where Optune Pax demonstrated a statistically significant improvement in overall survival without increasing systemic side effects. The treatment also extended the time to pain progression, improving the quality of life for patients with pancreatic cancer, according to Dr. Vincent Picozzi, a medical oncologist and investigator in the PANOVA-3 trial.
Optune Pax is a portable device that uses Tumor Treating Fields (TTFields) delivered through wearable arrays. TTFields are alternating electric fields that disrupt cancer cell division and survival without significantly affecting healthy cells.
Frank Leonard, CEO of Novocure, noted that this is the first new treatment in decades for locally advanced pancreatic cancer. He explained that systemic therapies have limited effectiveness due to poor bioavailability in pancreatic tumors, and that Optune Pax utilizes a biophysical approach targeting the unique electrical properties of cancer cells.
PanCAN’s Chief Scientific and Medical Officer, Anna Berkenblit, MD, MMSc, emphasized the importance of this approval for the pancreatic cancer community, highlighting the need for continued innovation in treating difficult-to-treat cancers.
The PANOVA-3 trial was an international, randomized, open-label, controlled Phase 3 clinical trial. It evaluated Optune Pax with gemcitabine and nab-paclitaxel as a first-line treatment for locally advanced pancreatic cancer, compared to gemcitabine and nab-paclitaxel alone. The trial enrolled 571 patients, randomized 1:1 and followed for at least 18 months.
The trial met its primary endpoint, showing a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax. In the intent-to-treat population (ITT), patients treated with Optune Pax alongside gemcitabine and nab-paclitaxel (n=285) had an mOS of 16.2 months [95% confidence interval (CI) 15.0-18.0], compared to 14.2 months (95% CI 12.8-15.4) for those treated with gemcitabine and nab-paclitaxel alone (n=286). This represents a 2.0-month improvement [hazard ratio (HR) 0.82; (95% CI 0.68 – 0.99) p=0.039].
In the modified per protocol (mPP) population, patients who received at least 28 days of Optune Pax therapy with gemcitabine and nab-paclitaxel (n=198) had an mOS of 18.3 months (95% CI 16.1-20.0), compared to 15.1 months (95% CI 13.4-17.0) for those treated with gemcitabine and nab-paclitaxel alone (n=207). This is a 3.2-month improvement [HR 0.77; (95% CI 0.62-0.97) p=0.023].
Optune Pax also demonstrated improvement in secondary endpoints, including the one-year survival rate. The one-year survival rate in the ITT population was 68.1% [95% CI 62.0–73.5] for the Optune Pax group, compared to 60.2% [95% CI 54.2–65.7] for the gemcitabine and nab-paclitaxel alone group.
In the mPP population, the one-year survival rate was 75.2% (95% CI 68.5, 80.7) for the Optune Pax group, compared to 65.9% (95% CI 59.0-72.0) for the gemcitabine and nab-paclitaxel alone group.
Patients treated with Optune Pax had a median time to pain progression of 15.2 months (95% CI 10.3–22.8), compared to 9.1 months in the group treated with gemcitabine and nab-paclitaxel alone (95% CI 7.4–12.7), representing a 6.1-month extension in time to pain progression.
Treatment with Optune Pax resulted in longer deterioration-free survival in global health status, pain, pancreatic pain, and most digestive problems. Similar trends were seen for emotional function and fatigue.
Optune Pax was well-tolerated and did not exacerbate gemcitabine/nab-paclitaxel-related systemic toxicity. The most common device-related skin adverse events (AEs) were mostly mild to moderate (Grade 1-2). Fatigue was reported in 14 participants (5.1%). There were no device-related AEs that led to death.
Pancreatic cancer is a highly lethal cancer and the third most frequent cause of cancer death in the U.S. The five-year relative survival rate is just 13%. Approximately 67,000 patients are diagnosed each year in the U.S.
Physicians use surgery, radiation, and pharmacological therapies depending on the stage of the disease. For locally advanced pancreatic cancer, the standard of care is surgery followed by chemotherapy with or without radiation. However, many cases are diagnosed when the cancer is no longer operable, leaving chemotherapy with or without radiation as the only option.
Optune Pax is a wearable therapeutic device used with gemcitabine and nab-paclitaxel, indicated for treating adult patients with locally advanced pancreatic cancer.
Optune Pax is not for everyone. It should not be used by individuals with an electrical implant, those with a known sensitivity to gels used on ECG stickers or TENS electrodes, or women who are pregnant or planning to become pregnant.
Patients should only use Optune Pax after receiving training from qualified personnel. They should not use any parts that did not come with the Optune Pax Treatment Kit and should avoid getting the device or transducer arrays wet.
Common side effects include low blood cell counts, diarrhea, nausea, fatigue, and skin-related disorders. Device-related skin adverse effects include inflammation, rash, itching, and irritation.
Tumor Treating Fields (TTFields) are electric fields that kill cancer cells via various mechanisms. TTFields do not significantly affect healthy cells due to their different properties compared to cancer cells.
Novocure is a global oncology company focused on extending survival in aggressive cancers through Tumor Treating Fields. Novocure’s products are approved in certain countries for treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. The company is headquartered in Baar, Switzerland, with U.S. headquarters in Portsmouth, New Hampshire, and R&D facilities in Haifa, Israel.
The results from the Phase 3 PANOVA-3 trial were published in the Journal of Clinical Oncology and are available online at https://ascopubs.org/doi/10.1200/JCO-25-00746.
Source: Novocure
