FDA Approves Noninvasive Optune Pax Device for Advanced Pancreatic Cancer

TUESDAY, Feb. 17, 2026 (HealthDay News) — The U.S. Food and Drug Administration has approved a first-of-its-kind, noninvasive device, the Optune Pax, for the treatment of adult patients with locally advanced pancreatic cancer.

Optune Pax is a portable, noninvasive device that delivers alternating electrical fields (tumor-treating fields [TTFields]) to the abdomen, which physically disrupt the rapid cell division that is characteristic of cancer cells while minimizing damage to healthy tissue. Treatment is administered through electrically insulated adhesive patches placed on the patient”s skin and connected to an electric field generator, which has unalterable treatment technological parameters preset by the manufacturer.

The premarket approval was based on data from a pivotal clinical study (PANOVA-3) conducted under an Investigational Device Exemption. Adult patients with locally advanced pancreatic cancer were randomly assigned to standard-of-care chemotherapies gemcitabine and nab-paclitaxel (GnP) with or without TTFields. Overall survival with Optune Pax was increased by approximately two months versus GnP alone. Localized skin reactions were the most common device-related adverse effects.

“In the phase 3 PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in overall survival without adding to the systemic side effects commonly associated with existing therapies,” Vincent Picozzi, M.D., an investigator in the PANOVA-3 trial, said in a statement. “It also significantly extended time to pain progression, helping to preserve overall quality of life, which is a priority when I am treating patients living with pancreatic cancer.”

Approval of Optune Pax was granted to Novocure.

More Information