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The U.S. Food and Drug Administration (FDA) has approved a wearable medical device used in combination with a standard chemotherapy regimen for the treatment of adult patients with locally advanced pancreatic cancer. The device, called Optune Pax®, delivers a treatment called Tumor Treating Fields Therapy (TTFields).
Optune Pax with the chemotherapy combination of gemcitabine and nab-paclitaxel is the first treatment to be FDA approved in nearly 30 years for locally advanced pancreatic cancer.
“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,” said PanCAN’s Chief Scientific and Medical Officer Anna Berkenblit, MD, MMSc, in a press release from oncology company Novocure announcing the FDA approval. “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.”
Medical oncologist Vincent Picozzi, M.D., MMM, a PanCAN Scientific and Medical Advisory Board member and investigator for the Phase III clinical trial that led to the treatment’s approval, calls the trial an important milestone as it is the first-ever positive randomized trial for locally advanced disease. He’s hopeful it will provide a foundation for future advances.
“[In the clinical 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,” Dr. Picozzi said. “With FDA approval, Optune Pax has the potential to be practice changing for the treatment of patients with locally advanced pancreatic cancer.”
In this blog post, PanCAN addresses questions related to this news.
What patients can receive this new treatment?
This treatment is approved for patients with unresectable, locally advanced pancreatic adenocarcinoma. This means that cancer has not spread far beyond their pancreas (has not metastasized) but has advanced to the point where it can’t be surgically removed.
What is Optune Pax? And what is TTFields?
Optune Pax is the wearable medical device developed by Novocure that delivers TTFields to patients with pancreatic cancer. 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, according to a statement about the approval from the FDA.
TTFields is a therapeutic option that has previously been approved by the FDA to treat glioblastoma, a type of tumor found in the brain and spinal cord, and metastatic non-small cell lung cancer. It uses electric fields to slow and reverse tumor growth by inhibiting mitosis (the process by which cells divide and replicate). TTFields does not significantly affect healthy cells because they have different properties than cancer cells.
What is the evidence for this treatment’s effectiveness for pancreatic cancer?
In December 2024, Novocure announced results from a Phase III clinical trial that studied the treatment as a first-line therapy (the first treatment given for a disease) for unresectable, locally advanced pancreatic adenocarcinoma. It enrolled 571 trial participants and they were randomly divided into two groups: One group received TTFields in combination with gemcitabine and nab-paclitaxel. The second group received gemcitabine and nab-paclitaxel alone.
At the end of the trial, participants who received the TTFields survived an average of two months longer than patients who received only the chemotherapies.
The overall survival benefit of two months for patients treated with TTFields is statistically significant, which means that it was unlikely to have occurred by chance. Specifically, patients who were treated with TTFields in addition to chemotherapy lived an average of 16.2 months, whereas patients treated with chemotherapy alone lived an average of 14.2 months.
Other notable results reported by the company: As compared to those treated with chemotherapy alone, patients treated with Optune Pax and the chemotherapy regimen reported six additional months until they experienced pain progression. This group of patients also reported improvement on several quality-of-life measures, such as digestive problems and fatigue.
Novocure presented their findings at the American Society of Clinical Oncology annual meeting and published results from the clinical trial at the American Society of Clinical Oncology annual meeting in May 2025.
What are the side effects?
The most common device-related side effect reported is mild to moderate skin irritation beneath the arrays. When TTFields are delivered, the arrays may cause mild warming and tingling of the skin underneath them.
I am a patient with pancreatic cancer interested in this treatment. What should I do?
People with locally advanced pancreatic cancer should talk to their healthcare team about this treatment option. Contact PanCAN Patient Services for additional information. Our expert Case Managers can provide patients and their caregivers with accurate, up-to-date information about this and other treatment options. Resources available to patients include personalized clinical trials searches, a list of specialists across the country and a free booklet with in-depth information specific to diagnosis and treatment.
Does insurance cover this treatment?
FDA approval means this drug combination is safe and effective, and although the FDA does not decide what is covered by insurance, when a drug gets FDA approval, Medicare and Medicaid will usually cover it. Coverage for cancer drugs will vary based on the specific plan and insurance company a person uses.
Contact PanCAN Patient Services for more information on financial assistance programs for those experiencing or anticipating cost-related barriers to care.
