FDA

FDA approves first-in-class device for pancreatic cancer

February 13, 2026

FDA has approved Optune Pax, a first‑of‑its‑kind, portable, noninvasive device that delivers tumor‑treating fields (TTFields) to the abdomen for adults with locally advanced pancreatic cancer. TTFields physically disrupt cancer cell division while sparing healthy tissue. The therapy is administered via adhesive skin patches connected to a wearable generator, allowing continuous home‑based treatment. Approval was supported by the phase 3 PANOVA‑3 trial (NCT03377491), which showed improved median overall survival when TTFields were added to gemcitabine and nab‑paclitaxel (16.2 vs. 14.2 months), along with higher one‑year survival rates (68.1% vs. 60.2%). Skin reactions were the most common adverse events.

Sources:

(2026, February 12). U.S. Food & Drug Administration. FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer

Babiker HM, et al; PANOVA-3 Study Investigators. (2025, July 20). J Clin Oncol. Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study. https://pubmed.ncbi.nlm.nih.gov/40448572/