Novocure wins CE Mark for Optune Pax pancreatic cancer use
- Novocure received CE Mark approval for Optune Pax in locally advanced pancreatic cancer treatment in Europe.
- The Phase 3 PANOVA-3 trial showed a 2-month median overall survival benefit versus chemotherapy alone.
- The device is planned for rollout in Germany in the coming weeks following prior U.S. approval.
Novocure (NASDAQ:NVCR) said its Optune Pax device has received CE Mark approval for treating adult patients with locally advanced pancreatic cancer of exocrine origin in combination with gemcitabine and nab-paclitaxel.
The approval is based on results from the Phase 3 PANOVA-3 trial, which showed improved overall survival compared with chemotherapy alone.
“In the Phase 3 PANOVA-3 trial for Optune Pax, a statistically significant improvement in overall survival was observed in patients who were at an advanced stage of disease,” said Hospital Clínic Barcelona Head of Medical Oncology Teresa Macarulla.
The study enrolled 571 patients and reported a median overall survival of 16.2 months for patients receiving Optune Pax plus chemotherapy versus 14.2 months for chemotherapy alone.
Novocure said the device also extended time to pain progression by 6.1 months and improved several quality-of-life measures in trial participants.
The company said it plans to launch Optune Pax in Germany in the coming weeks after previously securing U.S. Food and Drug Administration approval in February 2026.
