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On February 12, the U.S. Food and Drug Administration approved Novocure’s Optune Pax (NVCR, trading at $10.99 as of the last available quote, 02/14/26) to treat adult patients with locally advanced pancreatic cancer. The portable, non-invasive device delivers alternating electrical fields, called tumor treating fields (TTFields), to the abdomen.
The FDA positioned the decision as both an effort to address limited therapeutic options in pancreatic cancer and as aligned with its “Home as a Health Care Hub Initiative,” which emphasizes patient-centered devices intended to fit into daily life at home. FDA Commissioner Marty Makary said the pancreatic cancer community “deserves better therapeutic options.”
Optune Pax is administered through electrically insulated adhesive patches placed on the skin and connected to an electric field generator. Treatment parameters are preset by the manufacturer and cannot be adjusted by the patient or physician. Patients are trained to recharge batteries, place patches and replace arrays. The generator is carried in a specially designed bag to support continuous treatment during normal activities.
The FDA said the premarket approval pathway (PMA) decision was based on a pivotal randomized, controlled study conducted under an Investigational Device Exemption that followed patients for up to five years. Adding TTFields to gemcitabine in addition to nab-paclitaxel improved overall survival by approximately two months versus chemotherapy alone, and localized skin reactions were the most common device-related risks.
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