FDA Approves Device for Pancreas Care - Takeaways - MDSpire

FDA Approves Device for Pancreas Care

In the phase 3 PANOVA-3 trial, adding Tumor Treating Fields therapy to gemcitabine and nab-paclitaxel was associated with improved overall survival and delayed pain progression in adults with locally advanced pancreatic cancer.

  • By

  • Kathryn Wighton

  • February 12, 2026

  • 3 min

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    The FDA approved Optune Pax for adult patients with locally advanced pancreatic cancer, used with gemcitabine and nab-paclitaxel.

  • 2

    Approval was based on the PANOVA-3 trial, which showed improved overall survival and prolonged time to pain progression.

  • 3

    Optune Pax is a noninvasive device delivering Tumor Treating Fields through adhesive arrays on the abdomen.

  • 4

    The device was well tolerated, with most adverse events being mild and no new safety signals identified.

  • 5

    This marks the first new FDA-approved treatment for locally advanced pancreatic cancer in nearly 30 years.

Original Source(s)

FDA Approves Device for Pancreas Care

  • by Kathryn Wighton

  • February 12, 2026

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