The US Food and Drug Administration (FDA) has approved Optune Pax, a portable, non-invasive medical device for the treatment of adult patients with locally advanced pancreatic cancer. Developed by Novocure, the device delivers alternating electrical fields, known as tumour treating fields (TTFields), to the abdominal region to disrupt cancer cell division while limiting effects on healthy tissue.
The approval aligns with the FDA’s broader efforts to support innovation in medical devices and with its Home as a Health Care Hub initiative, which promotes patient-centred technologies that can be used outside traditional clinical settings. Optune Pax is designed for continuous use and can be worn during daily activities, enabling treatment to be administered in the home.
Therapy is delivered via electrically insulated adhesive patches applied to the skin and connected to an electric field generator. Treatment parameters are preset by the manufacturer and cannot be adjusted by patients or clinicians. Patients receive training on device operation, battery recharging, power supply connection, patch placement and regular replacement of the transducer arrays.
The device was approved through the FDA’s premarket approval (PMA) pathway, the Agency’s most stringent regulatory review process for medical devices. The decision was based on data from a pivotal, randomised, controlled clinical study conducted under an Investigational Device Exemption. The study followed adult patients with locally advanced pancreatic cancer for up to five years and evaluated Optune Pax in combination with standard-of-care chemotherapy (gemcitabine and nab-paclitaxel). Results showed an improvement in overall survival of approximately two months compared with chemotherapy alone. The most frequently reported device-related adverse events were localised skin reactions.
Optune Pax received Breakthrough Device designation in December 2024, reflecting its potential to address an unmet need in a life-threatening condition. Pancreatic cancer remains one of the most lethal malignancies, with high mortality driven by late diagnosis and limited treatment options.
