On August 20, 2025 Novocure (NASDAQ: NVCR) reported it submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for Tumor Treating Fields (TTFields) therapy for the treatment of locally advanced pancreatic cancer (Press release, NovoCure, AUG 20, 2025, View Source [SID1234655415]).
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This submission is supported by the PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median overall survival for patients treated with TTFields and GnP compared to GnP alone. The PANOVA-3 data was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, where the presentation was selected for inclusion in the "Best of ASCO (Free ASCO Whitepaper)" program. The data were simultaneously published in the Journal of Clinical Oncology.
"The submission of our application is a key step in our efforts to advance Tumor Treating Fields therapy as a treatment option for people living with pancreatic cancer," said Ashley Cordova, CEO, Novocure. "This milestone, achieved nine 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 PMA for pancreatic cancer was submitted as a PMA Panel-Track Supplement to Optune Lua, which is currently indicated for the treatment of patients with non-small cell lung cancer (NSCLC). The PMA supplement is expected to be converted to a separate, original PMA for the treatment of pancreatic cancer.
Novocure anticipates an approval decision in the second half of 2026.
About PANOVA-3
PANOVA-3 is an international, prospective, randomized, open-label, controlled Phase 3 clinical trial designed to test the efficacy and safety of Tumor Treating Fields (TTFields) therapy used concomitantly with gemcitabine and nab-paclitaxel, as a first-line treatment for locally advanced pancreatic adenocarcinoma. Patients were randomized to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone.
The primary endpoint is overall survival. Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.
Quality of life outcomes further reinforced the clinical benefit of TTFields therapy, with patients treated with TTFields therapy exhibiting a statistically significant extension in pain-free survival (secondary endpoint) and a significant preservation of quality of life in terms of global health status, pain, pancreatic pain, and digestive symptom domains.
TTFields therapy was well-tolerated, no new safety signals were observed, and safety was consistent with prior clinical studies. Mild to moderate skin adverse events (AEs) were the most common device-related AEs.
The PANOVA-3 trial enrolled 571 patients who were randomized 1:1 and followed for a minimum of 18 months.
About Tumor Treating Fields
Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.
To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.