FDA Approves Optune Pax for Locally Advanced Pancreatic Cancer

The FDA has granted approval to Optune Pax for concomitant use with gemcitabine and nab-paclitaxel (Abraxane) for the treatment of adult patients with locally advanced pancreatic cancer.^1,2 This first-of-its kind, portable, noninvasive device delivers tumor treating fields (TTFields)—alternating electrical fields that disrupt cancer cell division and minimize damage to healthy tissue—to the abdomen.

“Pancreatic cancer is one of the most challenging cancers to [manage], and patients have long needed new therapeutic options,” Michelle E. Tarver, MD, PhD, health director of the Center for Devices and Radiological Health, stated in a news release.¹ “This approval provides a novel, noninvasive approach that can be integrated into patients’ daily lives, expanding access to cancer care beyond traditional clinical settings.”

Approval of this device was obtained through the premarket approval process and supported by data from the phase 3 PANOVA-3 study (NCT03377491), which was conducted under an Investigational Device Exemption.^1,2 In this study, patients who received Optune Pax concomitantly with gemcitabine and nab-paclitaxel experienced a statistically significant 2-month improvement in median overall survival (OS; HR, 0.82; 95% CI 0.68-0.99; P = 0.039) compared with those who received gemcitabine plus nab-paclitaxel alone, meeting the study’s primary end point.² In the intent-to-treat (ITT) population, the median OS in the Optune Pax arm (n = 285) was 16.2 months (95% CI, 15.0-18.0) vs 14.2 months (95% CI, 12.8-15.4) in the gemcitabine/nab-paclitaxel arm (n = 286).

In the modified per protocol (mPP) population, defined as patients who received at least 28 days of Optune Pax concomitant with gemcitabine and nab-paclitaxel or at least 1 complete cycle of gemcitabine plus nab-paclitaxel alone, the median OS was 18.3 months (95% CI, 16.1-20.0) in the Optune Pax arm (n = 198) compared with 15.1 months (95% CI, 13.4-17.0) in the control arm (n=207; HR, 0.77; 95% CI 0.62-0.97; P = 0.023).

“In the PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in OS without adding to the systemic [adverse] effects [AEs] commonly associated with existing therapies. It also significantly extended time to pain progression, helping to preserve overall quality of life [QOL], which is a priority when I am treating patients living with pancreatic cancer,” Vincent Picozzi, MD, MMM, a medical oncologist and an investigator in the trial, added in a news release from NovoCure, the developer of Optune Pax. “With FDA approval, Optune Pax has the potential to be practice changing for the treatment of patients with locally advanced pancreatic cancer.”

Of note, the device also received FDA breakthrough device designation in December 2024.¹

What was the design of PANOVA-3?

PANOVA-3 was an international, prospective, randomized, open-label, controlled clinical trial designed to evaluate the use of Optune Pax concomitantly with gemcitabine and nab-paclitaxel in the first-line setting for patients with locally advanced pancreatic cancer.² The trial enrolled 571 patients, who were randomly assigned 1:1 to receive either Optune Pax plus gemcitabine and nab-paclitaxel, or gemcitabine plus nab-paclitaxel alone. Patients were followed for at least 18 months. The trial’s primary end point was median OS. Secondary end points included 1-year OS rate, progression-free survival (PFS), local PFS, objective response rate (ORR), puncture-free survival, tumor resectability rate (TRR), QOL, and pain-free survival.

What additional efficacy and safety data read out from PANOVA-3?

The Optune Pax combination also demonstrated improvement in several secondary end points. In the ITT population, the 1-year OS rate was 68.1% (95% CI, 62.0%-73.5%) with Optune Pax vs 60.2% (95% CI, 54.2%-65.7%) with gemcitabine/nab-paclitaxel alone. In the mPP population, the respective 1-year OS rates were 75.2% (95% CI, 68.5%-80.7%) and 65.9% (95% CI, 59.0%-72.0%).

Additionally, the patients treated with the Optune Pax regimen experienced a median time to pain progression of 15.2 months (95% CI 10.3-22.8) vs 9.1 months (95% CI, 7.4-12.7) with gemcitabine/nab-paclitaxel alone.

QOL, which was measured at baseline and every 8 weeks using the EORTC Quality of Life Questionnaire with the pancreatic cancer–specific PAN26 addendum, showed that the Optune Pax regimen prolonged deterioration-free survival in global health status, pain, pancreatic pain, and most digestive problems. Similar trends were observed for emotional function and fatigue/lack of energy.

No significant differences in the remaining secondary end points of PFS, local PFS, ORR, puncture-free survival, or TRR were observed between treatment arms.

Regarding safety, Optune Pax was well tolerated and did not increase systemic toxicity associated with gemcitabine plus nab-paclitaxel. No new safety signals were identified, and the rates of serious AEs were comparable between the study arms. Device-related skin AEs beneath the arrays were observed in 76.3% of patients treated with Optune Pax; most were grade 1 to 2 in severity, with grade 3 or higher skin AEs reported in 7.7% of patients.

The most common nondermatologic device-related AE was fatigue (5.1%). One grade 4 device-related AE, a neutrophil count decrease, was reported and classified as nonserious. No device-related AEs resulted in death, and no unexpected device-related safety issues were observed during the study.

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. US FDA approves Novocure’s Optune Pax for the treatment of locally advanced pancreatic cancer. News release. Novocure. February 11, 2026. Accessed February 12, 2026. https://www.novocure.com/us-fda-approves-novocures-optune-paxr-treatment-locally-advanced-pancreatic-cancer