FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer
- nuaxia
- Feb 16
- 1 min read
Wearable TTFields device now authorised in combination with chemotherapy following Phase III PANOVA-3 trial demonstrating overall survival benefit.
The FDA has approved Optune Pax, a wearable therapeutic device delivering Tumor Treating Fields (TTFields), for use with gemcitabine and nab-paclitaxel in adults with locally advanced pancreatic cancer.
Approval is based on the Phase III PANOVA-3 trial, which demonstrated a statistically significant improvement in overall survival, delayed pain progression, and offers a novel non-invasive therapy option for a disease with historically limited treatment choices.
Alert Type | Medical Device Approval (FDA) |
Drug/Device Name | Optune Pax |
Indication | Treatment of adult patients with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel |
Therapy Area(s) | Oncology |
Geography | US (FDA) |
What Changed | The U.S. FDA has approved the Optune Pax wearable therapeutic device — delivering Tumor Treating Fields (TTFields) — for use with chemotherapy in adults with locally advanced pancreatic cancer. The decision was based on statistically significant overall survival benefit in the Phase III PANOVA-3 trial. |
Clinical Relevance | Adds a novel non-invasive device-based therapy to standard chemotherapy for a disease with historically limited options, showing improved overall survival and delayed pain progression. |
Source Link | |
Date | 13-Feb-2026 |
Status | Draft |
Notes | Approval is through the FDA’s PMA pathway; TTFields are alternating electric fields targeting cancer cell division; trial enrolled 571 patients showing OS benefit. |
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