FDA Approves Optune Pax® in Combination With Chemotherapy for Locally Advanced Pancreatic Cancer

On February 11, 2026, the US Food and Drug Administration (FDA) approved Optune Pax® (Novocure) for the treatment of adult patients with locally advanced pancreatic cancer, to be used concomitantly with gemcitabine and nab-paclitaxel. 

Optune Pax is a wearable therapeutic device that noninvasively delivers Tumor Treating Fields (TTFields). TTFields are alternating electric fields that disrupt cancer cell replication, leading to cell death.

This approval is based on results from the phase 3 PANOVA-3 trial, an international, prospective, randomized, open-label, controlled trial evaluating Optune Pax in combination with gemcitabine and nab-paclitaxel as a first-line treatment.

The study enrolled a total of 571 patients with locally advanced pancreatic cancer. Patients were randomized 1:1 to receive Optune Pax plus gemcitabine and nab-paclitaxel (n = 285) or chemotherapy alone (n = 286) with a minimum follow-up of 18 months. 

The primary end point was overall survival (OS), analyzed in both the intent-to-treat (ITT) and modified per protocol populations, defined as patients who received ≥28 days of Optune Pax therapy with chemotherapy or at least 1 complete cycle of chemotherapy alone. Key secondary end points were 1-year survival, time to pain progression, and quality of life.

In the ITT population, median OS was 16.2 months (95% confidence interval [CI], 15.0 to 18.0) for patients receiving Optune Pax plus chemotherapy, compared with 14.2 months (95% CI, 12.8 to 15.4) for chemotherapy alone, representing a statistically significant improvement (hazard ratio [HR], 0.82; 95% CI, 0.68 to 0.99; P = .039). 

In the modified per protocol population, median OS was 18.3 months (95% CI, 16.1 to 20.0) in the Optune Pax arm (n = 198) compared to 15.1 months (95% CI, 13.4 to 17.0) in the chemotherapy alone arm (n = 207), also showing a statistically significant improvement (HR, 0.77; 95% CI, 0.62 to 0.97; P = .023).

The Optune Pax arm also showed a significant improvement in 1-year survival in both the ITT and modified per protocol populations. In the ITT population, the 1-year survival rate was 68.1% (95% CI, 62.0 to 73.5) with Optune Pax plus chemotherapy vs 60.2% (95% CI, 54.2 to 65.7) with chemotherapy alone. In the modified per protocol population, the 1-year survival rates were 75.2% (95% CI, 68.5 to 80.7) compared to 65.9% (95% CI, 59.0 to 72.0), respectively.

In addition, patients treated in the Optune Pax arm had a median time to pain progression of 15.2 months (95% CI, 10.3 to 22.8) compared to 9.1 months (95% CI, 7.4 to 12.7).

Quality of life was measured at baseline and every 8 weeks. The European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the pancreatic cancer-specific PAN26 addendum was used to analyze all patients. Results showed that treatment with Optune Pax plus chemotherapy resulted in extended deterioration-free survival in global health status, pain, pancreatic pain, and the majority of digestive symptoms, with similar trends noted for emotional function and fatigue.

Other secondary outcome measures including progression-free survival, local progression-free survival, objective response rate, puncture-free survival, and tumor resectability rate showed no significant differences between the 2 arms.

No new safety signals were observed with the addition of Optune Pax to chemotherapy. Serious adverse events were comparable between the study arms. Device-related skin adverse events (AEs) under the arrays were noted for 76.3% of patients treated with Optune Pax, 7.7% of which were Grade ≥3. Fatigue was the most common device-related non-skin AE and was reported in 14 participants (5.1%). One Grade 4 AE, neutrophil count decrease, was reported. No device-related deaths or unexpected safety issues were noted.

This approval expands first-line treatment options for patients with locally advanced pancreatic cancer, addressing an area of significant unmet need.

Source:

Business Wire. U.S. FDA Approves Novocure’s Optune Pax® for the Treatment of Locally Advanced Pancreatic Cancer. Accessed February 11, 2026. https://www.businesswire.com/news/home/20260211674921/en/U.S.-FDA-Approves-Novocures-Optune-Pax-for-the-Treatment-of-Locally-Advanced-Pancreatic-Cancer