Tumor Treating Fields Therapy Garners FDA Approval in Locally Advanced Pancreatic Cancer

The FDA has approved a new tumor treating fields (TTF) therapy, Optune Pax, for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel (GnP).¹

Optune Pax is a portable, wearable therapeutic device delivering TTF, or low-intensity alternating electric fields tuned to specific frequencies—in this case, 150 kHz—to the region of the malignant tumor. These fields disrupt cancer cell division replication and induce cell death with minimal damage to healthy cells.

This modality offers a potent, precise, and noninvasive approach to treating pancreatic cancer, where chemotherapy is the current standard of care. With this approval, the pancreatic cancer space moves toward more multimodal treatment strategies that combine chemotherapy’s systemic reach with the localized, inhibitory action of electric fields.

The regulatory decision is underpinned by positive data from the phase 3 PANOVA-3 trial (NCT03377491) in which the primary end point of overall survival (OS) was met. Patients treated with Optune Pax with GnP chemotherapy saw a significant 2-month improvement in OS, with a median OS of 16.2 months vs 14.2 months among those receiving GnP alone (HR, 0.82; 0.68-0.99; P =.039).²

In addition, pain-free survival was significantly prolonged with Optune Pax (HR, 0.74; 95% CI, 0.56-0.97; P =.027), underscoring its potential to improve quality of life for patients.

Because TTF does not share the same toxicity profile as systemic cytotoxic agents, they can be administered concurrently with standard chemotherapy without exacerbating common systemic adverse effects (AEs) such as myelosuppression or gastrointestinal distress. In the PANOVA-3 trial, Optune Pax was well tolerated; the most common AEs associated with the device was skin irritation beneath the transducer arrays (76.3%), which was expected with the device’s known mechanisms of action.

"In the [p]hase 3 PANOVA-3 trial, treatment with Optune Pax resulted in a statistically significant improvement in [OS] without adding to the systemic [AEs] 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, in a news release.¹ "With FDA approval, Optune Pax has the potential to be practice changing for the treatment of patients with locally advanced pancreatic cancer."

About the PANOVA-3 Trial

The PANOVA-3 trial was an international, randomized, open-label phase 3 trial evaluating Optune Pax concomitantly with GnP chemotherapy vs GnP alone as first-line treatment for patients with unresectable, locally advanced pancreatic cancer.³ The primary end point was OS; secondary end points included progression-free survival (PFS), local PFS, pain-free survival, overall response rate, and quality of life.

The trial enrolled a total of 581 adult patients, excluding those who have had prior palliative treatment to the tumor such as surgery or radiation. Patients were randomized 1:1 to receive either the investigational therapy or chemotherapy alone and were followed for a minimum of 18 months.

REFERENCES

1. U.S. 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://tinyurl.com/346detcn

2. Babiker HM, Picozzi V, Chandana SR, et al. Tumor treating fields with gemcitabine and nab-paclitaxel for locally advanced pancreatic adenocarcinoma: randomized, open-label, pivotal phase III PANOVA-3 study. J Clin Oncol. 2025;43(21):2350-2360. doi:10.1200/jco-25-00746

3. Effect of tumor treating fields (TTFields, 150 kHz) as front-line treatment of locally advanced pancreatic adenocarcinoma concomitant with gemcitabine and nab-paclitaxel (PANOVA-3). ClinicalTrials.gov. Updated January 21, 2026. Accessed February 12, 2026. https://clinicaltrials.gov/study/NCT03377491