On February 12, 2026, the FDA approved Optune Pax, a portable, wearable device that delivers tumor treating fields (TTFields), for the treatment of adult patients with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel.1 TTFields are alternating electric fields that target the unique electrical properties of cancer cells, disrupting cell division and survival without significantly affecting healthy cells. This approval marks the first new treatment in decades for locally advanced pancreatic cancer, offering a fundamentally different biophysical approach to treatment.
The FDA approval was supported by data from the phase 3 PANOVA-3 trial, an international, randomized, open-label study involving 571 patients. In this trial, patients receiving Optune Pax with gemcitabine and nab-paclitaxel demonstrated significant improvements in outcomes compared with those receiving gemcitabine and nab-paclitaxel alone. The median overall survival (mOS) in the intent-to-treat population was 16.2 months for the Optune Pax group versus 14.2 months for the control group, a statistically significant improvement of 2 months. In the modified per protocol population, mOS increased to 18.3 months compared with 15.1 months for the control group, reflecting a 3.2-month improvement. Additionally, the 1-year survival rate was higher in the Optune Pax group, reaching 68.1% in the intent-to-treat population and 75.2% in the modified per protocol population.
Optune Pax also demonstrated significant benefits in secondary end points, particularly in managing pain progression, which is a key clinical challenge in pancreatic cancer. Patients treated with the device experienced a median time to pain progression of 15.2 months compared with 9.1 months in the control group, a 6.1-month extension. Quality-of-life measures indicated longer deterioration-free survival across global health status, pain, pancreatic pain, digestive issues, emotional function, and fatigue.
Importantly, Optune Pax was well tolerated, with no exacerbation of systemic side effects typically associated with gemcitabine and nab-paclitaxel. Most device-related adverse events (AEs) were mild to moderate skin reactions under the arrays, with 7.7% experiencing grade ≥3 skin events. Other device-related AEs, such as fatigue, were rare and manageable, and no device-related adverse events led to death.
This approval is a milestone for the pancreatic cancer community, which has seen limited advancements and modest improvements in survival rates over time. Novocure’s CEO, Frank Leonard, emphasized the potential of Optune Pax to redefine treatment for locally advanced pancreatic cancer, providing hope for patients and healthcare providers. The approval highlights the importance of continued innovation in addressing difficult-to-treat cancers and improving patient outcomes.
Reference
- FDA approves Novocure’s Optune Pax for the treatment of locally advanced pancreatic cancer. www.novocure.com/us-fda-approves-novocures-opwtune-paxr-treatment-locally-advanced-pancreatic-cancer