The FDA has approved a new device to treat adults with locally advanced pancreatic cancer in combination with gemcitabine and nab-paclitaxel.
The device called Optune Pax, is a portable, wearable system that uses low-intensity electric fields to disrupt cancer cell division and help kill tumor cells without harming nearby healthy tissue. It is the first treatment approved in nearly 30 years for locally advanced pancreatic cancer.
The approval was based on results from the phase 3 PANOVA-3 trial, an international, prospective, randomized, open-label, controlled study that enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months, according to a Feb. 12 news release.
In the intent-to-treat population, patients treated with the device had a median overall survival of 16.2 months, compared to 14.2 months for those treated without the device.
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