FDA approves medical device for pancreatic cancer therapy—the first new treatment in 30 years
On Thursday, the U.S. Food and Drug Administration (FDA) approved the first therapy for pancreatic cancer in nearly 30 years in the form of a new medical device.
Developed by Novocure, the portable unit uses tumor treating fields (TTFs), delivered to the site of the cancer that aims to disrupt cell division without damaging healthy tissue. Essentially, the goal is to stop the disease from spreading by slowing the ability of cancer cells to replicate.
The TTF technology from the Optune Pax device subject to this approval is not new. In fact, these types of electronic field emitters have been approved for the treatment of numerous cancers, including glioblastoma, non-small cell lung cancer and mesothelioma.
This marks its first for pancreatic cancer—which, as FDA Commissioner Marty Makary, MD notes, is especially hard to treat and has a very high rate of fatalities.
“Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be. The pancreatic cancer community deserves better therapeutic options,” Makary said in an announcement. “The FDA is working tirelessly to bring potentially promising therapies to people who need them.”
As mentioned in the agency’s press release, data from the National Cancer Institute shows that pancreatic tumors and masses account for 3.3% of all new cases of the disease, or 51,980 deaths in 2025 alone.
Pancreatic cancer has a high rate of mortality not only because of late detection, but also because it's particularly aggressive and there are limited treatment options.
In 2025, there were 67,440 new cases diagnosed.
The nonprofit Pancreatic Cancer Action Network reports that the survival rate has been stalled at 13% for all cases, despite many cancers reaching rates of 70%. According to the group, this iteration of the disease remains the “deadliest major cancer” and the only one with a five-year survival rate below 20%.
In a statement from January, the group blamed, among other factors, a lack of treatment options for the lack of progress, in conjunction with a limited research investment compared to other illnesses.
“Pancreatic cancer remains on track to become the second leading cause of cancer-related death by 2030, a devastating reality that demands action,” Anna Berkenblit, MD, chief scientific and medical officer at Pancreatic Cancer Action Network, said. “We must accelerate research, expand early detection strategies, and ensure patients have access to innovative therapies. Every delay in action costs lives.”
The announcement from the group came a little over a month before the news from the FDA and Novocure, with statistics from 2025 and years prior in the spotlight.
Survival rate beats chemotherapy alone
The FDA did not say what outcomes data it used to approve the Optune Pax TTF device, but the system is designed to be used in conjunction with chemotherapy in order to be effective.
In its own press release, Novocure showed that its device, which is described as portable, increased overall survival rates at one year from 60.2% with chemotherapy alone to 68.1% when using TTFs. In specific terms, patient survival was shown to rise from 14.2 to 16.2 months in a Phase 3 clinical trial.
“In the Phase 3 PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in overall survival without adding to the systemic side effects commonly associated with existing therapies. It also significantly extended time to pain progression, helping to preserve overall quality of life, which is a priority when I am treating patients living with pancreatic cancer,” Vincent Picozzi, MD, medical oncologist and investigator in the study, said in a statement.
“With FDA approval, Optune Pax has the potential to be practice changing for the treatment of patients with locally advanced pancreatic cancer,” he added.
Notably, PANOVA-3 was a randomized controlled trial with international participation, “designed to evaluate the use of Optune Pax concomitantly” alongside chemotherapy in the treatment of pancreatic cancer, Novocure stated.
“The approval of Optune Pax is an important milestone for the pancreatic cancer community. Survival rates for pancreatic cancer have seen only modest improvements over time and treatment advances have remained limited, underscoring how challenging this disease is to treat,” PanCAN’s Chief Scientific and Medical Officer Anna Berkenblit, MD, said.
However, she noted, the FDA approval is limited to advanced stages where the cancer has not metastasized to other parts of the body.
“This approval for locally advanced disease highlights the importance of continued innovation and investment in new approaches for difficult-to-treat cancers and represents meaningful progress for patients who urgently need more options,” Berkenblit added.
The clinical trial involved 571 participants followed for 18 months, controlled for chemotherapy and the addition of Optune Pax, which yielded the increased survival rate findings.
The device administers electric signals through patches placed on the skin to target fields sent from a generator. Parameters for Optune Pax are set by the manufacturer and cannot be adjusted by anyone, including a provider, the FDA noted.
Patients are trained to use the device on their own, as it can be taken home. A bag containing the system can be worn for continuous treatment, with the user having to change pads and batteries as appropriate.
More instructions will be provided by doctors overseeing treatment.
‘Breakthrough’ designation made approval possible
Optune Pax was granted approval as part of the FDA’s Breakthrough Device Program, which allows for the rapid approval of medical technologies based on need in the market—with an emphasis on treatments for conditions that are rare or carry high rates of mortality.
The system was granted the fast track approval in December 2024, the FDA said. It’s now available for providers to use immediately.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.