FDA Approves Pancreatic Cancer Device That Extends Survival From Israeli-founded Novocure

The U.S. Food and Drug Administration has approved Israel-founded company Novocure to market a wearable device for the treatment of advanced pancreatic cancer, one of the deadliest forms of the disease.

The device, Optune Pax, uses high-frequency electric fields and is designed to be used in combination with standard chemotherapy drugs gemcitabine and nab-paclitaxel. The electrical treatment not only extended patients’ lives on average, but also delayed the worsening of pain by about six months.

The therapy is noninvasive and based on an unusual biophysical approach in oncology. Patients wear adhesive arrays attached to the skin near the tumor site. These arrays generate electric fields that interfere with cancer cell division. Because cancer cells divide rapidly and contain electrically charged structures during that process, the fields disrupt their activity, impairing the tumor’s ability to continue growing.

Novocure was founded as an Israeli startup in 2000 by Prof. Yoram Palti, an Israel Prize laureate for entrepreneurship, who died in January at 88. The company still operates a research and development center in Haifa, and some of its manufacturing takes place in Israel.

Its headquarters are now in Switzerland and it is led by CEO Frank Leonard. Novocure is traded on Nasdaq with a market capitalization of approximately $1.2 billion, after its share price lost about 95 percent of its value over the past five years.

The technology developed by Palti, a physiologist and biophysicist at the Technion – Israel Institute of Technology, is known as TTFields, short for tumor treating fields. It has previously been approved for use in glioblastoma, a type of brain cancer, and mesothelioma, a rare and aggressive cancer that develops in the thin layer of tissue lining the lungs.

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The new approval follows a large Phase 3 clinical trial. Median overall survival among patients who received the device alongside chemotherapy was 16.2 months, compared with 14.16 months among those who received chemotherapy alone.

The difference is statistically significant, meaning it is unlikely to be due to chance. While the average extension is about two months, in advanced pancreatic cancer – where treatment options are limited and prognosis is poor – even such an improvement is considered meaningful.

The study also examined the treatment’s effect on pain, one of the most severe symptoms of pancreatic cancer. The time until pain worsened was 15.2 months in the device group, compared with 9.1 months in the control group. In other words, adding the electrical therapy not only prolonged survival on average but also delayed the deterioration in patients’ quality of life.

The company says this is the first new treatment in decades for patients with locally advanced pancreatic cancer, a stage in which the tumor cannot be surgically removed but has not spread to distant organs. According to Novocure, many drugs struggle to penetrate pancreatic tissue effectively, limiting their impact.