U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer
Thursday, February 12, 2026
Novocure has received approval from the U.S. Food and Drug Administration (FDA) for Optune Pax® for the treatment of adults with locally advanced pancreatic cancer. The device is approved for use together with gemcitabine and nab-paclitaxel as a first-line treatment.
Optune Pax is a portable, wearable device that delivers Tumour Treating Fields (TTFields) through external arrays placed on the body. TTFields use alternating electric fields to disrupt cancer cell division by targeting the electrical properties of tumour cells. This approach aims to destroy cancer cells while largely sparing healthy tissue.
The approval is based on results from the Phase 3 PANOVA-3 clinical trial. This international, randomised, open-label study evaluated Optune Pax in combination with gemcitabine and nab-paclitaxel compared with chemotherapy alone. A total of 571 patients were enrolled and followed for at least 18 months.
The trial met its primary endpoint, showing a statistically significant improvement in median overall survival. In the intent-to-treat population, patients receiving Optune Pax with chemotherapy achieved a median overall survival of 16.2 months, compared with 14.2 months for those receiving chemotherapy alone. This represented a 2.0-month improvement.
In the modified per protocol population, which included patients who received at least 28 days of Optune Pax therapy or one complete chemotherapy cycle, median overall survival was 18.3 months in the combination group compared with 15.1 months in the chemotherapy-only group, reflecting a 3.2-month improvement.
The study also demonstrated improvements in several secondary endpoints. One-year survival rates were higher in patients treated with Optune Pax alongside chemotherapy in both the intent-to-treat and modified per protocol groups.
Pain control was another important outcome. Patients receiving Optune Pax experienced a median time to pain progression of 15.2 months, compared with 9.1 months in the chemotherapy-only group. This marked a 6.1-month extension before significant worsening of pain.
Quality of life was assessed using validated cancer-specific questionnaires. Patients treated with Optune Pax showed longer deterioration-free survival in global health status, pain measures and several digestive symptoms. Trends towards improvement were also observed in emotional function and fatigue.
No significant differences were reported between the two study arms for progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumour resectability rate.
Optune Pax was generally well tolerated and did not increase systemic side effects associated with chemotherapy. No new safety concerns were identified, and serious adverse events were similar in both groups. Most patients using the device experienced skin reactions beneath the arrays, which were mainly mild to moderate. A small proportion experienced more severe skin reactions. Fatigue was the most common non-skin device-related adverse event. No device-related deaths or unexpected safety issues were reported during the study.
Source: businesswire.com
