FDA Approves Optune Pax Device for Locally Advanced Pancreatic Cancer

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, marking the first new treatment modality approved for this indication in approximately 30 years.

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

TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue. 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 the phase III PANOVA-3 trial, which was 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 improved overall survival by approximately two months compared to chemotherapy alone. In the intent-to-treat population, median overall survival was 16.2 months in the Optune Pax group compared with 14.2 months in the chemotherapy-alone group. In the modified per protocol population, which included patients who received at least 28 days of device therapy or one full chemotherapy cycle, median overall survival reached 18.3 months with Optune Pax versus 15.1 months with chemotherapy alone, a 3.2-month improvement.

One-year survival rates also favored the Optune Pax arm. In the intent-to-treat population, 68.1% of patients receiving Optune Pax were alive at one year compared with 60.2% of those receiving chemotherapy alone. In the modified per protocol group, one-year survival rates were 75.2% versus 65.9%, respectively.

There were also improvements shown in the secondary endpoints of 1-year survival; median time to pain progression; and longer deterioration-free survival in global health status, pain, pancreatic pain, and most of the digestive problems. Median time to pain progression was 15.2 months in the Optune Pax group compared with 9.1 months in the chemotherapy-alone group, extending pain control by 6.1 months. Localized skin reactions were the most common device-related risks observed in the study. Serious adverse events were comparable between study arms, and Optune Pax did not increase chemotherapy-related systemic toxicities.

"Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options," said the Center for Devices and Radiological Health Director. "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 approval reflects the FDA's 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.

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.