FDA Approves Optune Pax® Plus Chemotherapy for Locally Advanced Pancreatic Cancer

Key Clinical Summary: 

• Design/Population: PANOVA-3 was a large, multinational, phase 3 trial enrolling more than 500 patients with locally advanced pancreatic cancer randomized to gemcitabine plus nab-paclitaxel with or without tumor-treating fields.
• Key Outcomes: The addition of tumor-treating fields resulted in a statistically significant overall survival benefit, delayed systemic progression, and meaningful improvements in quality-of-life parameters, including prolonged freedom from pain progression.
• Clinical Relevance: FDA approval of tumor-treating fields introduces a novel, device-based modality into frontline management of locally advanced pancreatic cancer and may provide a platform for future therapeutic combinations.

Vincent Picozzi, MD, Virginia Mason Medical Center, Seattle, Washington, discusses results from the PANOVA-3 trial, which demonstrated that tumor-treating fields (TTFields) plus gemcitabine and nab-paclitaxel significantly improved outcomes compared to standard chemotherapy among patients with locally advanced pancreatic cancer.

These data led to the recent FDA approval of Optune Pax, a wearable therapeutic device that noninvasively delivers TTFields, when used concomitantly with gemcitabine and nab-paclitaxel for the treatment of patients with locally advanced pancreatic cancer.

Transcript:

My name is Dr Vince Picozzi, I'm a medical oncologist at the Virginia Mason Clinic in Seattle, Washington, and the director of the pancreatobiliary program here. It's my pleasure to visit with you for several moments about tumor-treating fields in pancreatic cancer. 

As you may be aware, the FDA just recently approved the use of this technology in locally advanced pancreatic cancer. The basis for this approval was the PANOVA-3 trial which was a large, multi-continental, multi-international, phase 3 trial of over 500 patients in which gemcitabine and [nab-paclitaxel], given in standard dose and schedule, were randomized either to the use of tumor-treating fields or not.

This trial produced a number of significant results, the first of which was a statistically significant survival advantage in favor of use of the device and interestingly, this survival advantage was associated with a delay in systemic disease progression. Secondly, there was a significant improvement in virtually all quality-of-life parameters as formally assessed by questionnaire, and most particularly a freedom from pain progression for over 7 months. 

In addition to improvements in both quality and quantity-of-life, things that are very significant to patients being treated with a disease that's generally not curable, the device also proved to be facile to use. Patients were able to use it on average for over 14 hours a day, and really, the only significant incremental side effect was skin toxicity, which did compromise use in about 7 or 8 percent of patients.

With that top-line information, the FDA did see fit to approve this device, something that I'm personally very excited about and plan to introduce in my practice immediately. I think the device can produce immediate advantages for patients in the study population identified both by PANOVA-3 and the FDA, but also I think the device and its use will provide a platform for further investigation and further therapeutic advance. 

The device is being tested in metastatic pancreatic cancer in conjunction with a checkpoint inhibitor and also offers potential synergy with a variety of agents being developed for pancreatic cancer including KRAS inhibitors, immunotherapy, and PARP inhibitors. I believe what we're seeing is just the beginning of the use of this device in pancreatic cancer and related diseases, with further expansive usage to come.

Source: 

Business Wire. US FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer. Accessed February 20, 2026. https://www.businesswire.com/news/home/20260211674921/en/U.S.-FDA-Approves-Novocures-Optune-Pax-for-the-Treatment-of-Locally-Advanced-Pancreatic-Cancer