FDA Approval of Optune Pax for Pancreatic Cancer

FDA Commissioner Marty Makary: "The pancreatic community deserves better therapeutic options."

The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with locally advanced pancreatic cancer. Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue.

“Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be. The pancreatic cancer community deserves better therapeutic options,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA is working tirelessly to bring potentially promising therapies to people who need them.”

The approval reflects the FDA’s unwavering commitment to advancing safe and effective medical devices that address chronic diseases and improve the lives of Americans and is also aligned with the FDA’s Home as a Health Care Hub Initiative, which focuses on advancing the development of innovative, patient-centered devices that fit more seamlessly into people’s daily lives at home.    

“Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “This approval provides a novel, non-invasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings.”

According to information published by the National Cancer Institute, pancreatic cancer was expected to result in approximately 67,440 new diagnoses and 51,980 deaths in the U.S. in 2025. Pancreatic cancer accounts for roughly 3.3% of all new cancer cases but represents a disproportionately large share of cancer deaths due to its late detection, aggressive disease behavior, and limited treatment options.

The therapy is administered through electrically insulated adhesive patches that are placed on the patient’s skin and connected to an electric field generator. Device treatment technological parameters are preset by the manufacturer and cannot be adjusted by the patient or physician. 

Patients are trained on how to use the device, including how to recharge and replace device batteries, connect the device to an external power supply, place the adhesive patches in the appropriate positions on the body, and replace the transducer arrays at least twice per week. The device is designed to be worn with the generator carried in a specially designed bag, allowing patients to receive continuous treatment while going about their normal daily activities.

Optune Pax was approved through the premarket approval (PMA) pathway, the FDA’s most rigorous review process for medical devices. The FDA’s approval of Optune Pax is based on data from a pivotal clinical study conducted under an Investigational Device Exemption. The randomized and controlled study followed adult patients with locally advanced pancreatic cancer for up to five years. The results showed that the addition of TTFields to standard of care chemotherapies gemcitabine and nab-paclitaxel (GnP) improved Overall Survival by approximately two months compared to GnP alone. Localized skin reactions were the most common device-related risks observed in the study. The results of this study formed the basis for the FDA’s PMA approval decision.

The FDA granted Breakthrough Device designation for the Optune Pax device in December 2024. 

A breakthrough designation is meant to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.