Novocure's Optune Pax, a wearable medical device using Tumor Treating Fields (TTFields), has received a CE (Conformit Europenne) Mark for treating adult patients with locally advanced pancreatic cancer of exocrine origin. The approval is based on the Phase 3 PANOVA-3 trial, which demonstrated a statistically significant improvement in median overall survival (mOS) for patients treated with Optune Pax alongside gemcitabine and nab-paclitaxel (gem/nab-pac) compared to gem/nab-pac alone. In the intent-to-treat (ITT) population, mOS was 16.2 months with Optune Pax vs. 14.2 months without, a 2.0-month improvement. In the modified intent-to-treat (mITT) population (patients receiving at least 28 days of Optune Pax), mOS was 18.3 months with Optune Pax vs. 15.1 months without, a 3.2-month improvement. The treatment also significantly delayed pain progression, a key secondary endpoint, with a median time to pain progression of 15.2 months compared to 9.1 months for gem/nab-pac alone, a 6.1-month extension. Quality of life measures also showed longer deterioration-free survival in global health status, pain, and digestive problems. Optune Pax was well-tolerated, with no new safety signals and comparable serious adverse events between arms. Most device-related adverse events were mild to moderate skin reactions. The CE Mark intended purpose includes a reference to guideline recommendations to account for market variations in gemcitabine and nab-paclitaxel use. Novocure plans to launch Optune Pax in Germany in the coming weeks.