FDA Approves First-in-Class Optune Pax Device for Pancreatic Cancer

The FDA approved Optune Pax (Novocure), a first-in-class portable device that delivers tumor-treating fields (TTFields) to the abdomen in adult patients with locally advanced pancreatic cancer, representing a novel treatment approach that enables home-based care.¹

The device, which was approved for concomitant use with gemcitabine and nab-paclitaxel (Abraxane; Bristol Myers Squibb),² works by delivering alternating electrical fields to the abdomen through electrically insulated adhesive patches placed on the patient's skin. TTFields physically disrupt the rapid cell division characteristic of cancer cells while minimizing damage to healthy tissue.¹ It is the first locally advanced pancreatic cancer treatment to be FDA approved in almost 3 decades.²

Pancreatic cancer was expected to result in approximately 67,440 new diagnoses and 51,980 deaths in the US in 2025, according to data from the National Cancer Institute.³ The disease accounts for roughly 3.3% of all new cancer cases but represents a disproportionately large share of cancer deaths. In December 2024, the FDA granted breakthrough device designation for Optune Pax.¹

"Having treated many patients with pancreatic cancer, I know how difficult the diagnosis can be,” FDA Commissioner Marty Makary, MD, MPH, said in a statement.¹ “The pancreatic cancer community deserves better therapeutic options. The FDA is working tirelessly to bring potentially promising therapies to people who need them.”

Optune Pax received approval through the premarket approval pathway based on data from a pivotal clinical study conducted under an Investigational Device Exemption.^1,2

The randomized, controlled phase 3 PANOVA-3 study (NCT03377491) followed 571 adult patients with locally advanced pancreatic cancer receiving gemcitabine plus nab-paclitaxel alone (n = 286) or patients concomitantly using Optune Pax (n = 285) for up to 5 years.^1,2 Results demonstrated that adding TTFields to standard chemotherapy with gemcitabine and nab-paclitaxel statistically significantly improved overall survival by 2 months (HR, 0.82; 95% CI, 0.68-0.99; P = .039) compared with those who received gemcitabine plus nab-paclitaxel alone. In the intent-to-treat population, the median overall survival (OS) in the Optune Pax arm was 16.2 months (95% CI, 15.0-18.0) compared with 14.2 months (95% CI, 12.8-15.4) in the gemcitabine plus nab-paclitaxel alone arm.

Among patients who received at least 28 days of Optune Pax with gemcitabine and nab-paclitaxel (n = 198) or at least 1 complete cycle of gemcitabine plus nab-paclitaxel alone (n = 207)—the modified per-protocol population—the median OS was 18.3 months in the Optune Pax arm (95% CI, 16.1-20.0) compared with 15.1 months in the control arm (95% CI, 13.4-17.0). This translates to a 33% improvement in OS in this population (HR, 0.77; 95% CI, 0.62-0.97; P = .023).

In the Optune Pax group, most patients (76.3%) experienced device-related skin adverse events (AEs) beneath the arrays. Most were grade 1 to 2 in severity, with grade 3 or higher skin AEs reported in 7.7% of patients. Fatigue was the most common nondermatologic device-related AE, affecting 5.1% of patients. Rates of serious AEs were similar between the study arms, and Optune Pax did not worsen systemic toxicities related to gemcitabine and nab-paclitaxel.

“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,” Vincent Picozzi, MD, MMM, medical oncologist and investigator in the PANOVA-3 trial, said in a statement.² “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. With FDA approval, Optune Pax has the potential to be practice-changing for the treatment of patients with locally advanced pancreatic cancer.”

The approval provides patients and clinicians with a new tool in managing locally advanced pancreatic cancer, a disease that has historically had limited therapeutic options and poor outcomes. By enabling home-based administration, the device may help reduce the burden of frequent clinic visits while maintaining continuous cancer therapy.

"Pancreatic cancer is one of the most challenging cancers to treat, and patients have long needed new therapeutic options," Michelle Tarver, MD, PhD, director of the FDA Center for Devices and Radiological Health, said in a statement.¹ "This approval provides a novel, non-invasive approach that can be integrated into patients' daily lives, expanding access to cancer care beyond traditional clinical settings."

References

1. FDA approves first-of-its-kind device to treat pancreatic cancer. News release. FDA. February 12, 2026. Accessed February 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-device-treat-pancreatic-cancer

2. U.S. FDA approves Novocure’s Optune Pax for the treatment of locally advanced pancreatic cancer. News release. Zai Lab. February 12, 2026. Accessed February 12, 2026. https://ir.zailaboratory.com/news-releases/news-release-details/us-fda-approves-novocures-optune-paxr-treatment-locally-advanced

3. Cancer stat facts: pancreatic cancer. National Cancer Institute Surveillance, Epidemiology, and End Results Program. Accessed February 12, 2026. https://seer.cancer.gov/statfacts/html/pancreas.html