The wearable system uses alternating electrical fields to disrupt cancer cell division and can be used continuously during daily activities.
The US Food and Drug Administration (FDA) has approved a device it calls a first-of-its-kind 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.
“The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer. Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells,” says Frank Leonard, CEO of Novocure, in a release.
The approval is 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,” says Center for Devices and Radiological Health director Michelle Tarver, MD, PhD, in a release. “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 US 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.
Home Therapy for Pancreatic Cancer
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.
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