U.S. FDA — First-of-its-kind “tumor treating fields” Device Cleared for Pancreatic Cancer Alongside Chemo

Washington, D.C. — The U.S. Food and Drug Administration on Thursday approved Optune Pax, a portable device designed to treat adults with locally advanced pancreatic cancer by delivering “tumor treating fields” (TTFields) to the abdomen — a non-invasive therapy patients can use while continuing daily routines at home.

Optune Pax, made by Novocure, uses alternating electrical fields that disrupt cancer cell division while aiming to limit harm to healthy tissue, the agency said. The device is worn using adhesive patches placed on the skin and connected to a small generator carried in a dedicated bag. Patients receive training to place and replace the arrays at least twice a week and manage power and battery charging.

The approval was granted through the FDA’s premarket approval (PMA) pathway and aligns with the agency’s “Home as a Health Care Hub” initiative to support more patient-centered, home-friendly device care.

The FDA said its decision was based on a randomized controlled study that followed patients for up to five years and tested TTFields in addition to standard chemotherapy with gemcitabine and nab-paclitaxel. In published reports about the same trial, median overall survival was about 16.2 months with TTFields plus chemotherapy versus 14.2 months with chemotherapy alone. Localized skin reactions were the most common device-related risk.

What parents and caregivers can do now: ask the oncology team whether the patient is eligible, what daily wear-time is recommended, and how to manage skin care and device supplies at home. The FDA said patients should check with their care team for training and follow-up plans.