A “first-of-its-kind” medical device that uses electrical fields to treat locally advanced pancreatic cancer among adults has been approved for use in the United States, the Food and Drug Administration said in a Feb. 12 statement.
“Optune Pax, developed by Novocure, is a portable, non-invasive device that delivers alternating electrical fields, known as tumor treating fields (TTFields), to the abdomen. TTFields work by physically disrupting the rapid cell division that is characteristic of cancer cells, while minimizing damage to healthy tissue,” the FDA said.
“The therapy is administered through electrically insulated adhesive patches that are placed on the patient’s skin and connected to an electric field generator.
“The device is designed to be worn with the generator carried in a specially designed bag, allowing patients to receive continuous treatment while going about their normal daily activities.”
The treatment parameters are preset by the manufacturer in the device. These parameters cannot be adjusted either by patients or physicians.
Patients will be trained to use the device, including replacing batteries and recharging, replacing transducer arrays at least twice per week, and placing adhesive patches in the correct positions on the body.
The pancreas sits behind the stomach. While there is no clear answer to what causes pancreatic cancers, gene mutations are considered a potential cause of illness, according to the American Cancer Society.
Out of the various types of pancreatic cancer, the most common is pancreatic adenocarcinoma, which typically starts in the organ’s ducts.
There were an estimated 67,440 new cases of pancreatic cancer in 2025, making up 3.3 percent of all new cancer cases, according to data from the National Cancer Institute. An estimated 51,980 individuals died from the disease last year, indicating a high mortality rate, and accounting for 8.4 percent of all cancer deaths.
“Approximately 1.6 percent of men and women will be diagnosed with pancreatic cancer at some point during their lifetime,” the institute said.
The FDA granted the Optune Pax device a Breakthrough Device designation in December 2024. Such designations are issued to expedite device development that is deemed to offer effective treatment for life-threatening or irreversibly debilitating conditions.
The device was approved via the premarket approval pathway, the FDA’s “most rigorous review process” for medical devices.
“Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be. The pancreatic cancer community deserves better therapeutic options,” FDA Commissioner Marty Makary said.
Side Effects
In a Feb. 11 statement, Novocure said a phase 3 trial of the device had shown “statistically significant improvement in overall survival” among patients.However, the company warned that there could be potential side effects of using Optune Pax together with chemotherapy drugs, including diarrhea, low white blood cell count, vomiting, pneumonia, urinary tract infection, high blood sugar, shortness of breath, and an increase in liver enzymes.
The device’s arrays can also overheat, leading to local skin burns, the company said. Novocure advised patients to speak with their doctors if experiencing such side effects.
According to an April 30 post from the American Cancer Society, tobacco use is one of the most important risk factors for pancreatic cancer.
“The risk of getting pancreatic cancer is about twice as high among people who smoke compared to those who have never smoked. About 25 percent of pancreatic cancers are thought to be caused by cigarette smoking. Cigar smoking and the use of smokeless tobacco products also increase the risk,” the group said.
“It’s never too late to stop smoking, since the risk of pancreatic cancer will drop once a person stops smoking.”
In addition to smoking, other risk factors include excess body weight, diabetes, workplace exposure to certain chemicals, family history of the illness, and old age.
