FDA Approves First Pancreatic Cancer Device in 30 Years

For the first time in nearly 30 years, the FDA has approved a new treatment option for people with locally advanced pancreatic cancer, offering hope to thousands of patients facing one of medicine's toughest challenges.

The agency approved Optune Pax, a wearable device that delivers electric fields to slow tumor growth when combined with standard chemotherapy. Patients wear the device in a specially designed bag while going about their daily activities, receiving continuous treatment without hospital visits.

The approval stems from a clinical trial involving 571 patients with pancreatic cancer that had spread beyond the pancreas but couldn't be surgically removed. Those who used Optune Pax alongside chemotherapy lived an average of 16.2 months compared to 14.2 months for patients receiving chemotherapy alone.

Beyond the two extra months of life, the treatment delivered something equally meaningful to patients. Those using the device experienced six additional months before pain worsened and reported improvements in digestive problems and fatigue.

Dr. Vincent Picozzi, who helped lead the trial, calls it practice changing for pancreatic cancer care. "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," he said.

The device works by delivering Tumor Treating Fields, which use electric fields to disrupt how cancer cells divide and replicate. Healthy cells remain largely unaffected because they have different properties than cancer cells. The FDA previously approved the same technology for brain tumors and lung cancer.

The most common side effect is mild to moderate skin irritation where the device contacts the body, along with possible warming and tingling sensations. These effects are manageable for most patients.

Why This Inspires

Pancreatic cancer has long frustrated researchers and devastated families, with survival rates improving only modestly over decades. This breakthrough proves that persistent innovation can crack even the toughest medical challenges.

The approval represents more than just statistics. It gives patients precious extra time with loved ones while maintaining their quality of life and reducing pain. Every additional month matters deeply to families facing this diagnosis.

Dr. Anna Berkenblit of the Pancreatic Cancer Action Network emphasized the importance of continued investment in difficult cancers. The success of this trial provides a foundation for future advances that could bring even greater improvements.

Patients with locally advanced pancreatic cancer can now discuss this option with their healthcare teams, opening a door that has been closed for three decades.