Novocure announced 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.

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) Annual Meeting, where the presentation was selected for inclusion in the “Best of ASCO” 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.