Novocure Ltd. has announced the submission of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Tumor Treating Fields (TTFields) therapy aimed at treating locally advanced pancreatic cancer. This application marks a significant step forward in Novocure's efforts to expand the use of TTFields therapy, which has already shown promise in treating non-small cell lung cancer (NSCLC). The submission, supported by the positive outcomes of the PANOVA-3 trial, is anticipated to receive an approval decision in the second half of 2026. The PANOVA-3 trial demonstrated a statistically significant improvement in median overall survival when TTFields was used in combination with standard chemotherapy, compared to chemotherapy alone. The results were highlighted at the 2025 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology.
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