The U.S. Food and Drug Administration has approved a first-of-its-kind wearable device developed by Novocure for the treatment of locally advanced pancreatic cancer using electric fields. The device is used in combination with the chemotherapy drugs gemcitabine and nab-paclitaxel.
The regulatory green light follows the publication of positive Phase III clinical trial results for the Optune Pax device, which demonstrated a median overall survival of 16.2 months compared to 14.2 months in the control group. The trial also assessed pain levels—a critical endpoint in pancreatic cancer care. The study showed that treatment with Optune Pax plus chemotherapy resulted in a median time to pain progression of 15.2 months, versus 9.1 months without the device.
“The approval of Optune Pax marks the first new treatment in nearly 30 years for patients battling locally advanced pancreatic cancer,” said Novocure CEO Frank Leonard. “Our technology represents a fundamentally different approach—a biophysical one—that targets the electrical properties of cancer cells.”
Optune Pax utilizes Tumor Treating Fields (TTFields) technology—low-intensity alternating electric fields. Applied via adhesive patches placed on the skin, the device disrupts charged structures inside cancer cells (specifically the proteins tubulin and septin) that are essential for cell division. The fields cause these proteins to spin chaotically, preventing them from forming the mitotic spindle. If a cancer cell does manage to begin dividing and takes on an hourglass shape, an “electric sieve” effect occurs: organelles are dragged toward the narrow bridge, and the cell is mechanically torn apart. Because the fields are tuned to specific frequencies, they primarily affect rapidly dividing cancer cells while largely sparing healthy tissue.
Devices based on this technology are already FDA-approved for the treatment of glioblastoma and mesothelioma.
