Novocure Files Premarket Approval Application to FDA for Tumor Treating Fields Therapy in Locally Advanced Pancreatic Cancer

Novacure has submitted a premarket approval application to the FDA for its Tumor Treating Fields (TTFields) therapy to treat locally advanced pancreatic cancer. According to Novacure, TTFields are electric fields that “exert physical forces to kill cancer cells via a variety of mechanisms” and “do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells.” A decision on the application is expected in the second half of 2026.1

The submission is based on findings from the phase 3 PANOVA-3 trial (NCT03377491). The addition of TTFields to gemcitabine and nab-paclitaxel (Abraxane) as frontline therapy for patients with unresectable, locally advanced pancreatic adenocarcinoma produced a statistically significant and clinically meaningful improvement in overall survival (OS) vs gemcitabine and nab-paclitaxel alone (median, 16.2 months [95% CI, 15.0-18.0] vs 14.2 months [95% CI, 12.8-15.4]; HR, 0.82; 95% CI, 0.68-0.99; log-rank P = .039).2

“The submission of our application is a key step in our efforts to advance [TTFields] therapy as a treatment option for people living with pancreatic cancer,” Ashley Cordova, CEO of Novocure, said in a news release.1 “This milestone, achieved 9 months after the positive topline readout of the PANOVA-3 trial, reflects the focus, drive, and commitment of our team to bring this innovative treatment to patients as quickly as possible.”

The international, open-label PANOVA-3 trial enrolled 571 patients who were randomly assigned 1:1 to TTFields plus gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.2

TTFields (150 kHz) was administered via the NovoTTF-200T System with a recommended average usage of at least 75% (ie, for at least 18 hours per day). Patients in both arms also received 125 mg/m2 of intravenous (IV) nab-paclitaxel once daily before receiving 1000 mg/m2 of IV gemcitabine once daily on days 1, 8, and 15 of each 28-day cycle. Treatment was continued until local disease progression according to RECIST 1.1, lack of compliance, intolerable toxicity, pregnancy, or consent withdrawal.2

The primary end point of the study was OS. Secondary end points included progression-free survival (PFS), local PFS, overall response rate (ORR), 1-year survival rate, quality of life (QOL), pain-free survival, puncture-free survival, resectability rate, and toxicity.2

The median patient age was 67 years (range, 31-90), and most patients were female (52.4%), White (71.1%), and from either North America (43.4%) or Western Europe and Israel (21.5%). Most patients had an ECOG performance status of 1 (57.6%) and a BMI less than 25 (59.5%). The most common target lesion site was the head of the pancreas (51.0%), and carbohydrate antigen 19-9 levels were moderate (38-1000 U/mL) in most cases (51.1%).2

Additional findings from the trial, which were presented at the 2025 American Society of Clinical Oncology Annual Meeting, demonstrated a median pain-free survival of 15.2 months (95% CI, 10.3-22.8) and 9.1 months (95% CI, 7.4-12.7) with and without TTFields, respectively (HR, 0.74; 95% CI, 0.56-0.97; P = .027). Distant PFS was also significantly prolonged, with a median of 13.9 months (95% CI, 12.2-16.8) with TTFields vs 11.5 months (95% CI, 10.4-12.9) with chemotherapy alone (HR, 0.74; 95% CI, 0.57-0.96; log-rank P = .022). However, 3 other key secondary end points, PFS, local PFS, and ORR, were not improved with the addition of TTFields to chemotherapy.2

With respect to safety, TTFields was well tolerated with no reports of new-onset toxicity,2 mirroring its profile from past clinical trials.1 Mild to moderate skin adverse effects (AEs) were the most common device-related AEs.2

QOL data also demonstrated a statistically significant prolongation in pain-free survival and a significant preservation of QOL as measured by global health status, pain, pancreatic pain, and digestive symptom domains.2

References

1. Novocure submits premarket approval application to FDA for Tumor Treating Fields therapy in locally advanced pancreatic cancer. News release. Novocure. August 20, 2025. Accessed August 20, 2025. https://www.novocure.com/novocure-submits-premarket-approval-application-fda-tumor-treating-fields-therapy-locally-advanced
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