FDA Alert

FDA Approves Therapeutic Device for Locally Advanced Pancreatic Cancer in the United States

Edited by:
Ashton L. Stahl

Key Highlights

• FDA grants premarket approval to a portable device delivering alternating electrical fields for locally advanced pancreatic cancer.
• The approval was supported by randomized controlled clinical data showing improved overall survival when added to gemcitabine and nab-paclitaxel.
• The device can be worn during normal daily activities, expanding treatment beyond traditional clinical settings.

The FDA has approved the first medical device of its kind indicated for adult patients with locally advanced pancreatic cancer. The portable device, Optune Pax, delivers tumor-treating fields (TTFields), low-intensity alternating electric fields, to disrupt cancer cell division while limiting harm to healthy tissue. The portable, non-invasive device is intended for use alongside standard chemotherapy with gemcitabine and nab-paclitaxel.

The FDA’s decision was based on findings from a pivotal, randomized, controlled clinical study conducted under an Investigational Device Exemption. The trial followed adult patients with locally advanced pancreatic cancer for up to 5 years and demonstrated that adding TTFields delivered by the portable device to standard care improved overall survival by approximately 2 months compared with chemotherapy alone.

“Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options,” Michelle Tarver, MD, PhD, director of the FDA’s Center for Devices and Radiological Health, said in a press release.

The most commonly reported device-related adverse events were localized skin reactions at the sites where the transducer arrays contact the skin.

Optune Pax is designed for continuous use during daily activities; therapeutic parameters are preset and not adjustable by clinicians or patients. Users are trained in patch placement, device operation, battery management, and array replacement at least twice weekly.

References

U.S. Food and Drug Administration. FDA approves first-of-its-kind device to treat pancreatic cancer. Published February 12, 2026. Accessed February 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer