FDA Approves Device for Pancreas Care
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By
February 12, 2026
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3 min
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1
FDA approved Optune Pax for pancreatic cancer.
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Supports use with gemcitabine and nab-paclitaxel.
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3
Median overall survival increased to 16 months.
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4
Prolonged time to pain progression by 6 months.
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5
Non-invasive device with low adverse events.
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6
First treatment approval for this cancer in 30 years.
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7
PANOVA-3 trial involved 571 patients.
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8
Device well tolerated with grade 1 or 2 skin events.
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The FDA has approved Optune Pax, a novel noninvasive device designed for use with gemcitabine and nab-paclitaxel in treating adult patients with locally advanced pancreatic cancer. This approval stemmed from the PANOVA-3 phase 3 trial, which demonstrated that Optune Pax enhances median overall survival, increasing it to 16 months in the treatment group compared to 14 months in those receiving chemotherapy alone. The device offers benefits like prolonged time to pain progression and improved quality of life, marking the first new FDA-approved treatment for this cancer type in nearly three decades.
-
1
FDA approved Optune Pax for pancreatic cancer.
-
2
Supports use with gemcitabine and nab-paclitaxel.
-
3
Median overall survival increased to 16 months.
-
4
Prolonged time to pain progression by 6 months.
-
5
Non-invasive device with low adverse events.
-
6
First treatment approval for this cancer in 30 years.
-
7
PANOVA-3 trial involved 571 patients.
-
8
Device well tolerated with grade 1 or 2 skin events.
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