FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer

For the first time in approximately 30 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment for adults with locally advanced pancreatic cancer, the regulatory agency announced.

“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,” Dr. Vincent Picozzi, medical oncologist and investigator of the PANOVA-3 trial, said in a news release from Novocure. “With FDA approval, Optune Pax has the potential to be practice changing for the treatment of patients with locally advanced pancreatic cancer.”

Optune Pax delivers Tumor Treating Fields (TTFields), alternating electric fields designed to disrupt cancer cell division. With this approval, patients with locally advanced pancreatic cancer now have access to a novel, noninvasive treatment approach that works differently from standard systemic therapies.

Optune Pax Improves Overall Survival and Delays Pain Progression

The approval was based on findings from PANOVA-3, an international, randomized phase 3 trial evaluating Optune Pax in combination with gemcitabine and nab-paclitaxel as first-line therapy. A total of 571 patients were randomly assigned to receive chemotherapy alone or chemotherapy plus Optune Pax and were followed for a minimum of 18 months.

In the intent-to-treat population, median overall survival was 16.2 months in the Optune Pax group compared with 14.2 months in the chemotherapy-alone group. This represented a statistically significant two-month improvement. In the modified per protocol population, which included patients who received at least 28 days of device therapy or one full chemotherapy cycle, median overall survival reached 18.3 months with Optune Pax versus 15.1 months with chemotherapy alone, a 3.2-month improvement.

One-year survival rates also favored the Optune Pax arm. In the intent-to-treat population, 68.1% of patients receiving Optune Pax were alive at one year compared with 60.2% of those receiving chemotherapy alone. In the modified per protocol group, one-year survival rates were 75.2% versus 65.9%, respectively.

Pain control remains a major concern in pancreatic cancer. In PANOVA-3, median time to pain progression was 15.2 months in the Optune Pax group compared with 9.1 months in the chemotherapy-alone group, extending pain control by 6.1 months. Quality-of-life assessments showed longer deterioration-free survival in global health status, pancreatic pain and several digestive symptoms among patients receiving the device.

There were no significant differences between treatment arms in progression-free survival, objective response rate or tumor resectability.

Understanding Tumor Treating Fields in Pancreatic Cancer

Pancreatic cancer is one of the most lethal malignancies and is the third leading cause of cancer-related death in the United States. Approximately 67,000 individuals are diagnosed each year, and the five-year relative survival rate is 13%. Incidence and mortality rates continue to rise despite advances in other cancer types.

Locally advanced pancreatic cancer typically involves major blood vessels, making surgery difficult or impossible in many cases. For patients who are not candidates for surgery, chemotherapy with or without radiation has remained the primary treatment approach.

Optune Pax introduces a biophysical strategy. The device delivers TTFields through wearable arrays placed on the abdomen. These alternating electric fields interfere with the electrical properties of rapidly dividing cancer cells, disrupting mitosis and leading to cancer cell death. Healthy cells are less affected due to differences in division rate and electrical characteristics.

Safety, Patient Eligibility and What to Expect

Optune Pax is indicated for adult patients with locally advanced pancreatic cancer when used with gemcitabine and nab-paclitaxel. The device is portable and worn continuously, with arrays applied to the skin.

In PANOVA-3, Optune Pax was generally well tolerated and did not increase chemotherapy-related systemic toxicities. Serious adverse events were comparable between study arms. The most common device-related side effects were skin reactions beneath the arrays, reported in 76.3% of treated patients. Most were mild to moderate. Approximately 7.7% experienced grade 3 (severe) or higher skin events. Fatigue was the most common non-skin device-related side effects.

There were no device-related side effects leading to death and no unanticipated safety concerns identified during the study.

Optune Pax is not recommended for patients with certain electrical implants or known sensitivity to conductive gels. It should not be used during pregnancy. Patients must receive proper training before starting therapy and should avoid getting the device wet.

Additional Findings and Clinical Impact

Beyond overall survival and pain control, patients receiving Optune Pax experienced longer deterioration-free survival in measures of global health, emotional functioning and fatigue. These findings suggest that adding TTFields therapy may help preserve quality of life in addition to extending survival.

The PANOVA-3 results were published in the Journal of Clinical Oncology. Advocacy leaders have described the approval as an important milestone for a disease in which therapeutic progress has been limited.

With this decision, Optune Pax becomes the first new FDA-approved treatment for locally advanced pancreatic cancer in decades. For patients and families navigating this diagnosis, the addition of a novel, noninvasive therapy offers a meaningful new option in a setting where innovation has been urgently needed.

References

1. “FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer,” by the U.S. Food and Drug Administration. News release; Feb. 12, 2026
2. “U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer,” by Novocure. News release; Feb. 11, 2026.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI and reviewed by a human editor.

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