FDA Approves TTFields Plus Chemo in Locally Advanced Pancreatic Cancer

The FDA has approved Optune Pax, a portable, non-invasive device that delivers alternating electrical fields, or tumor treating fields (TTFields), to the abdomen, for the treatment of patients with locally advanced pancreatic cancer, according to a press release from the agency.¹

Previously, the Optune Pax device was granted breakthrough therapy designation in December 2024. In August 2025, the developers submitted a premarket approval application for the device in this population.²

The approval, and all other indicaitons in this population, were supported by findings from the pivotal, international, phase 3 PANOVA-3 trial (NCT03377491), which evaluated the safety and efficacy of TTFields plus chemotherapy vs chemotherapy alone in the frontline setting.

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

Clinical Efficacy

Results from PANOVA-3 were most recently shared at the 2025 American Society of Clinical Oncology (ASCO) Annual Meetingand simultaneously published in the Journal of Clinical Oncology.³ In the intention-to-treat population of 571 patients, the combination of TTFields and chemotherapy produced a median overall survival (OS) of 16.2 months (95% CI, 15.0-18.0) compared with 14.2 months (95% CI, 12.8-15.4) for those receiving chemotherapy alone (HR, 0.82; 95% CI, 0.68-0.99; P = .039). The 1-year survival rate was significantly higher in the experimental arm at 68.1% compared with 60.2% in the control arm (P = .029).

Secondary efficacy end points further demonstrated the benefit of adding TTFields to standard-of-care chemotherapy. Although the median progression-free survival (PFS) did not reach statistical significance between the 2 arms (10.6 months vs 9.3 months; HR, 0.85; P = .137), investigators observed a significant improvement in median pain-free survival. Patients in the TTFields group experienced a median pain-free survival of 15.2 months (95% CI, 10.3-22.8) vs 9.1 months (95% CI, 7.4-12.7) in the chemotherapy-only group (HR, 0.74; 95% CI, 0.56-0.97; P = .027). Furthermore, the objective response rate (ORR) was 36.1% with the TTFields regimen vs 30.0% with chemotherapy alone.

“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 Center for Devices and Radiological Health of the FDA, added in the release.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.”

Trial Design

PANOVA-3 randomly assigned patients in a 1:1 ratio to receive either continuous TTFields plus chemotherapy (n = 244) or chemotherapy alone (n = 243) until disease progression in the abdomen. The treatment regimen for both arms included nab-paclitaxel at 125 mg/m², thengemcitabine at a dose of 1000 mg/m², both administered as intravenous infusions on days 1, 8, and 15 of every 28-day cycle. TTFields were delivered at a frequency of 150 kHz via the NovoTTF-200T System, with a recommended average use of 75% or more; array placement was adapted to individual patients.

Eligible patients included those 18 years or older with histologically or cytologically confirmed, unresectable, locally advanced, biopsy-confirmed, and previously untreated pancreatic adenocarcinoma. Participants were required to have an ECOG performance status of 0 to 2 and a life expectancy of at least 3 months.

Safety Data

The addition of TTFields to gemcitabine and nab-paclitaxel did not exacerbate systemic toxicities. Any-grade adverse effects (AEs) occurred in 97.8% of the experimental arm and 98.9% of the control arm, with grade 3 or higher AEs reported in 88.7% and 84.3%, respectively.

The most frequent grade 3 or higher toxicities were hematologic, including neutropenia (47.8% vs 47.6%), anemia (21.9% vs 22.3%), and leukopenia (17.2% vs 15.4%). Device-related AEs were primarily dermatological, with skin reactions occurring in 76.3% of patients treated with TTFields. Discontinuation of the device due to toxicity occurred in 8.4% of patients.

References

1. FDA approves first-of-its-kind device to treat pancreatic cancer. News release. FDA. February 12, 2026. Accessed February 12, 2026. https://tinyurl.com/2un5n8hx
2. Novocure submits premarket approval application to FDA for tumor treating fields therapy in locally advanced pancreatic cancer. News release. Novocure. August 20, 2025. Accessed February 12, 2026. https://tinyurl.com/mvckpzcf
3. 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