For the treatment of locally advanced pancreatic cancer, an application for premarket approval for its Tumor Treating Fields (TTFields) therapy has been submitted to the U.S. Food and Drug Administration by Novocure.This submission is a significant step in the company's efforts to provide a new treatment option for patients with this aggressive form of cancer. The application is supported by the positive outcomes of the PANOVA-3 trial.
The PANOVA-3 trial was a Phase 3 clinical study that evaluated the use of TTFields therapy in combination with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment. The trial successfully met its primary endpoint, showing a statistically significant and clinically meaningful improvement in median overall survival for patients who received the combined therapy compared to those who received GnP alone. The compelling data from this trial were not only presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where it was featured in the “Best of ASCO” program, but were also published simultaneously in the Journal of Clinical Oncology. According to Novocure’s CEO, Ashley Cordova, this submission, which occurred just nine months after the trial's positive topline results, highlights the company's commitment to expediting the availability of this innovative treatment.
The premarket approval for pancreatic cancer was filed as a supplement to the existing Optune Lua®, which is already approved for non-small cell lung cancer. This supplement is expected to be converted into a distinct, original premarket approval for pancreatic cancer. Novocure has a projected timeline for an FDA decision, anticipating a final approval decision in the second half of 2026.
The PANOVA-3 trial, which was an international, prospective, randomized, open-label, controlled study, involved 571 patients. Secondary endpoints of the trial reinforced the clinical benefits of TTFields, demonstrating a statistically significant extension in pain-free survival and a significant preservation of quality of life in domains such as global health status and pain. Furthermore, the therapy was well-tolerated, with no new safety signals identified. The most common device-related side effects were mild to moderate skin adverse events, consistent with previous clinical studies.
Tumor Treating Fields are electric fields that work by exerting physical forces to kill cancer cells, while having minimal effect on healthy cells due to their distinct properties. This multimechanistic action allows TTFields therapy to be combined with other cancer treatment modalities. Novocure is a global oncology company focused on extending the survival of patients with aggressive cancers through the development and commercialization of this innovative therapy. The company has multiple ongoing and completed clinical trials and its products are commercially approved in several countries for various cancers, including glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma.