Novocure Wins FDA Nod for Optune Pax Pancreatic Cancer Treatment

Novocure announced U.S. Food and Drug Administration for Optune Pax to treat adults with locally advanced pancreatic cancer concomitant with gemcitabine and nabpaclitaxel.

Optune Pax is a portable therapeutic device that delivers Tumor Treating Fields (TTFields) non-invasively through wearable arrays. TTFields are alternating electric fields that target cancer cells’ electrical properties to disrupt processes for cell division and survival. This results in cell death without significantly affecting healthy cells.

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

Data supporting Optune Pax’s FDA approval

The PANOVA-trial evaluated use of Optune Pax concomitantly with gemcitabine and nab-paclitaxel (gem/nab-pac) as a first-line treatment for locally advanced pancreatic cancer compared to gem/nab-pac alone. It enrolled 571 patients who were followed for a minimum of 18 months.

The trial met its primary endpoint, showing significant improvement in median overall survival (mOS) for patients treated with Optune Pax. Patients in the intent-to-treat (ITT) population treated with the device had an mOS of 16.2 months compared to 14.2 months for those treated with gem/nab-pac alone.

In the modified per protocol (mPP) population (defined as patients who received at least 28 days of Optune Pax therapy concomitant with gem/nab-pac arm or at least one complete cycle of gem/nab-pac), patients treated with the device has an mOs of 18.3 months compared to 15.1 months for those treated with gem/nab-pac alone.

“The FDA approval of Optune Pax marks the first new treatment in decades for people living with locally advanced pancreatic cancer. Systemic therapies have shown poor bioavailability in pancreatic tumors, limiting their effectiveness. Optune Pax is a fundamentally different treatment, utilizing a biophysical approach that targets the unique electrical properties of cancer cells,” said Frank Leonard, CEO of Novocure. “This is a proud moment for Novocure and we look forward to bringing Optune Pax to patients and the healthcare providers who care for them.”

In December 2025, the company announced Leonard’s promotion to CEO. He boasts an over 15-year career at the company.