FDA Approves TTFields Device With Chemo in Pancreatic Cancer

The FDA has approved Optune Pax, a wearable medical device that delivers Tumor Treating Fields (TTFields), for the treatment of adult patients with locally advanced pancreatic cancer (LA-PAC) alongside gemcitabine and nab-paclitaxel, according to a news release from the device’s developer, Novocure.¹

This decision marks the first new treatment approach approved for the locally advanced pancreatic cancer population in approximately 30 years, Novocure stated in the release. TTFields are non-invasive, alternating electric fields that target the unique electrical properties of cancer cells to disrupt processes needed for cell division and survival. By exerting physical forces on cancer cells, TTFields cause cell death while generally sparing healthy cells, which have different electrical and morphological properties.

PANOVA-3 Trial Findings

The approval was supported by results from PANOVA-3 (NCT03377491), a global, randomized, open-label, pivotal phase 3 clinical trial. The study enrolled 571 patients with newly diagnosed, unresectable LA-PAC and randomized them 1:1 to receive either gemcitabine and nab-paclitaxel alone or the chemotherapy combination with Optune Pax. The primary end point of the trial was overall survival (OS).

In the intention-to-treat (ITT) population, treatment with Optune Pax and chemotherapy resulted in a statistically significant improvement in median OS, reaching 16.2 months (95% CI, 15.0-18.0) compared with 14.2 months (95% CI, 12.8-15.4) for patients receiving chemotherapy alone (HR, 0.82; 95% CI, 0.68-0.99; P = .039).

The 1-year survival rate in the ITT population was also significantly improved at 68.1% (95% CI, 62.0%-73.5%) in the Optune Pax arm versus 60.2% (95% CI, 54.2%-65.7%) in the control arm. In the modified per protocol population (defined as patients who received at least 1 full cycle of chemotherapy or at least 28 days of device therapy), the median OS benefit was more pronounced at 18.3 months (95% CI, 16.1-20.0) compared with 15.1 months (95% CI, 13.4-17.0; HR, 0.77; 95% CI, 0.62-0.97; P = .023).

The trial also demonstrated significant benefits in secondary and post hoc end points. Median time to pain progression was extended by 6.1 months, reaching 15.2 months (95% CI, 10.3-22.8) with the device compared to 9.1 months (95% CI, 7.4-12.7) with chemotherapy alone (HR, 0.74; 95% CI, 0.56-0.97; P = .027). Additionally, distant progression-free survival (PFS) was significantly improved at 13.9 months (95% CI, 12.2-16.8) vs 11.5 months (95% CI,10.4-12.9; HR, 0.74; P = .022). No significant differences were observed in secondary measures of objective response rate, local PFS, or resectability rates.

The Safety Profile of Optune Pax

The addition of Optune Pax did not exacerbate the systemic toxicities typically associated with gemcitabine and nab-paclitaxel. Serious adverse events (AEs) were comparable between study arms. Device-related AEs were largely localized skin reactions beneath the wearable arrays, occurring in 76.3% of treated patients. The majority of these skin events were mild to moderate (grade 1 or 2); however, 7.7% of patients experienced a grade 3 or worse skin event. The most common skin reactions included dermatitis, rash, pruritus, maculopapular rash, and erythema. Non-skin device-related adverse events included fatigue, reported by 5.1% of participants. Clinical management of skin reactions typically involves array site rotation and the use of topical steroids or calcineurin creams.

Administration and Clinical Considerations for Optune Pax

Optune Pax is recommended at a daily usage of at least 75% (approximately 18 hours per day). In the PANOVA-3 trial, the median daily device usage was 62.1%.

Contraindications for Optune Pax include the presence of active electrical implants (such as pacemakers), known sensitivity to medical hydrogels, and pregnancy.

References

1. U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer. Novocure. News release. February 11, 2026. Accessed February 12, 2026. https://www.novocure.com/us-fda-approves-novocures-optune-paxr-treatment-locally-advanced-pancreatic-cancer
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