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Novocure Submits Premarket Approval Application to FDA for Tumor Treating Fields Therapy in Locally Advanced Pancreatic Cancer
BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today announced it submitted a premarket approval (PMA) application to the U.S. Food and Drug
About this update from Novocure Limited
[{"type":"text","content":" BAAR, Switzerland--(BUSINESS WIRE)--\nNovocure (NASDAQ: NVCR) today 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.\n\n\nThis 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.\n\n\n“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.”\n\n\nThe 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.\n\n\nNovocure anticipates an approval decision in the second half of 2026.\n\n\nAbout PANOVA-3\n\n\nPANOVA-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.\n\n\nThe primary endpoint is o...