The Swiss oncology therapy company Novocure has announced that its innovative medical device, Optune Pax, has received the European Union's CE certification. The approval is for use in combination with the chemotherapy regimen of gemcitabine and nab-paclitaxel as a first-line treatment for adults with locally advanced, unresectable pancreatic cancer.
Optune Pax is a portable, wearable device that delivers low-intensity (150 kHz) alternating electric fields, known as Tumor Treating Fields, to the tumor site via electrode patches placed on the abdomen. This therapy uses electric fields at a specific frequency to physically interfere with the arrangement of key proteins during cancer cell mitosis, thereby inhibiting proliferation and inducing cell death. Due to differences in electrical properties between normal cells and cancer cells, the therapy is designed to cause limited damage to healthy tissue.
The approval is primarily based on data from a pivotal Phase 3 clinical trial named PANOVA-3. This study enrolled 571 patients across 196 global centers, making it one of the largest prospective, randomized controlled trials in the pancreatic cancer field in recent years. Results showed that in the intent-to-treat population, patients receiving Optune Pax combined with chemotherapy achieved a median overall survival of 16.2 months, compared to 14.2 months for the chemotherapy-alone group—an extension of 2 months, representing an 18% reduction in the risk of death. In the per-protocol population with device usage exceeding 28 days, median survival reached 18.3 months, a 3.2-month extension compared to the 15.1 months in the control group.
In addition to extending survival, the therapy demonstrated significant advantages in alleviating cancer-related pain. Data indicated that the median time to pain progression was significantly extended from 9.1 months in the control group to 15.2 months in the combination therapy group—an improvement of 6.1 months. Regarding safety, the most common side effects were mild-to-moderate skin reactions related to electrode contact, and the therapy did not increase the systemic toxicity of the chemotherapy.
Pancreatic cancer is often referred to as the "king of cancers" due to its extremely poor prognosis and a five-year survival rate of only about 13%. This CE certification marks another major milestone following its prior approval from the U.S. Food and Drug Administration (FDA). Novocure stated it will promptly advance market launch efforts in key European countries such as Germany, offering a meaningful therapeutic breakthrough for a field that has long lacked effective new treatments.