The U.S. FDA has approved Optune Pax, a first-of-its-kind wearable device from Novocure, for use in combination with gemcitabine and nab-paclitaxel in patients with locally advanced pancreatic cancer.
The system delivers tumor treating fields (TTFields) — low-intensity alternating electric fields that disrupt cancer cell division — through adhesive arrays worn on the abdomen and connected to a portable generator.
Key Data: PANOVA-3 Trial
- Median overall survival: 16.2 months (TTFields + chemo) vs 14.2 months (chemo alone)
- Pain-free survival: 15.2 months vs 9.1 months
- In a modified per-protocol analysis, median OS reached 18.3 months vs 15.1 months
There was no difference in progression-free survival, but the overall survival and pain control signals supported approval.
Safety & Practical Considerations
- Most common side effect: localized skin reactions (~75%, 7.7% grade ≥3)
- Approximate cost: $21,000 per month
- Requires continuous wear with battery changes and array replacements twice weekly
TTFields are already approved in glioblastoma, mesothelioma, and metastatic NSCLC. This marks the first new FDA approval for locally advanced pancreatic cancer in nearly 30 years, according to the company.