FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer

The Food and Drug Administration this month approved Optune Pax, from Novocure—a wearable tumor-treating fields (TTFields) device that uses electric fields to kill cancer cells—for the treatment of pancreatic cancer, in combination with chemotherapy. As the first new approved therapy for locally advanced pancreatic cancer in nearly three decades, the device was described by a clinical trial investigator as having the potential to be practice changing.

The new pancreatic cancer approval is supported by results from the Phase III PANOVA-3 trial, which showed patients with inoperable locally advanced pancreatic cancer who used Optune Pax in combination with gemcitabine and nab-paclitaxel (Abraxane) chemotherapy had delayed pain progression, from 9.1 months to 15.2 months, and improved overall survival, from 60% to 68% at one year. Study results were presented at the 2025 ASCO annual meeting and published in the Journal of Clinical Oncology.

TTFields therapy takes advantage of cancer cells’ unique electrical properties and rapid growth to interfere with processes critical for their survival while sparing healthy cells. The portable Optune Pax device delivers alternating low-intensity electric fields via an array of wearable electrodes on the abdomen to disrupt cancer cell replication.

According to the director of the FDA’s Center for Devices and Radiological Health, the approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings. TTFields therapy was previously approved for glioblastoma brain cancer, non-small-cell lung cancer and pleural mesothelioma.

TTFields therapy is generally safe and well tolerated. The most common side effect in people using the Optune device is mild to moderate skin irritation, though the accompanying chemotherapy can come with other adverse effects.