RegulatoryJun 30, 2026, 07:06 AM
NovoCure Optune Pax® Receives CE Mark for Pancreatic Cancer
AI Summary
NovoCure announced that its medical device, Optune Pax®, has received CE Mark approval for the treatment of adult patients with locally-advanced pancreatic cancer of exocrine origin. The approval is for use alongside gemcitabine and nab-paclitaxel chemotherapy. This designation is supported by positive results from the Phase 3 PANOVA-3 clinical trial, which demonstrated a statistically significant improvement in overall survival and a significant delay in pain progression for patients treated with Optune Pax. The company plans to launch Optune Pax in Germany in the coming weeks.
Key Highlights
- Optune Pax® received CE Mark for locally-advanced pancreatic cancer in adults.
- Approval is for use concomitant with gemcitabine and nab-paclitaxel.
- Supported by Phase 3 PANOVA-3 trial showing statistically significant improvement in overall survival.
- Median overall survival (ITT) was 16.2 months with Optune Pax vs 14.2 months for control.
- Median time to pain progression was 15.2 months with Optune Pax vs 9.1 months for control.
- Optune Pax was well-tolerated with no new safety signals observed in the trial.
- Novocure plans to launch Optune Pax in Germany in the coming weeks.
- Optune Pax was previously approved by the U.S. FDA in February 2026.
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