Novocure Receives Approval for Optune Pax® in Locally Advanced Pancreatic Cancer
Thursday, February 12, 2026
Novocure has announced that the U.S. Food and Drug Administration (FDA) has approved Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer.
Pancreatic cancer remains one of the most aggressive cancers and is currently the third leading cause of cancer-related deaths in the United States. Around 67,000 people are diagnosed each year in the country, and the five-year relative survival rate stands at approximately 13%. While outcomes for many cancers have improved, survival rates for pancreatic cancer have changed only modestly.
Treatment options depend on the stage of the disease and may include surgery, chemotherapy and radiotherapy. However, many patients with locally advanced disease are diagnosed at a stage when surgery is no longer possible. In such cases, chemotherapy with or without radiation has traditionally been the main treatment option. The approval of Optune Pax introduces a new therapeutic approach for this patient group.
Optune Pax is a portable, wearable device that delivers Tumour Treating Fields (TTFields). These are alternating electric fields designed to interfere with cancer cell division by targeting the electrical properties of tumour cells. This biophysical approach aims to slow tumour growth and promote cancer cell death, while limiting damage to healthy cells.
Optune Pax was generally well tolerated. It did not increase chemotherapy-related systemic toxicity, and serious adverse events were comparable between both arms. Most patients using the device experienced skin reactions beneath the arrays, reported in 76.3% of treated participants. These events were mainly mild to moderate, with 7.7% experiencing Grade 3 or higher reactions. Fatigue was the most common non-skin device-related adverse event, affecting 5.1% of patients. No device-related deaths or unexpected safety concerns were reported.
The device is approved for use alongside gemcitabine and nab-paclitaxel as a first-line treatment.
The approval is based on results from the Phase 3 PANOVA-3 clinical trial. This international, prospective, randomised, open-label study enrolled 571 patients with locally advanced pancreatic cancer.
Patients treated with Optune Pax showed longer deterioration-free survival in global health status, pain, pancreatic pain and several digestive symptoms. Similar trends were observed in emotional function and fatigue.
There were no significant differences between the two groups in progression-free survival, local progression-free survival, objective response rate, puncture-free survival or tumour resectability.
Source: novocure.com
