Oncology company Novocure (NASDAQ: NVCR) announced on Wednesday that it has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Tumor Treating Fields (TTFields) therapy in locally advanced pancreatic cancer. The submission is supported by the PANOVA-3 Phase 3 trial, which demonstrated a statistically significant and clinically meaningful improvement in median overall survival for patients receiving TTFields therapy alongside gemcitabine and nab-paclitaxel (GnP), compared with GnP alone. PANOVA-3 enrolled 571 patients and results were presented at the 2025 ASCO Annual Meeting and published in the Journal of Clinical Oncology.

PMA submission was filed as a Panel-Track Supplement to Optune Lua, currently indicated for non-small cell lung cancer (NSCLC), and is expected to convert to a separate original PMA for pancreatic cancer. Novocure anticipates an FDA decision in the second half of 2026.

TTFields therapy demonstrated significant extension in pain-free survival and preservation of quality of life across global health, pain, pancreatic pain and digestive symptom domains. Safety findings were consistent with prior studies, with mild to moderate skin adverse events the most common device-related effects.

TTFields deliver electric fields that selectively disrupt cancer cells through multiple mechanisms, sparing healthy tissue. Therapy can be combined with chemotherapy, radiotherapy, immune checkpoint inhibitors, or targeted therapies, offering clinical versatility across solid tumor types.

Novocure is headquartered in Baar, Switzerland, with US operations in Portsmouth, New Hampshire, and research facilities in Haifa, Israel. Its TTFields therapy is approved in select markets for glioblastoma, NSCLC and malignant pleural mesothelioma, with ongoing trials exploring additional solid tumour indications.