Novocure Secures FDA Approval for Tumor Treating Fields in Pancreatic Cancer

Novocure has received approval from the US Food and Drug Administration for Optune Pax, its tumor treating fields (TTF) therapy for locally advanced pancreatic cancer. The device was cleared via the premarket approval pathway after a clinical trial demonstrated a statistically significant two-month improvement in overall survival.

In a 571-patient study, median overall survival reached 16.2 months for patients receiving TTF therapy alongside gemcitabine and nab-paclitaxel, compared with 14.2 months for chemotherapy alone. While progression-free survival and response rates were unchanged, pain-free survival improved to 15.2 months versus 9.1 months in the control group.

Novocure’s technology uses low-intensity alternating electric fields to disrupt cancer cell division while sparing healthy tissue. A prior device, NovoTTF-100A, was approved in 2011 for glioblastoma. The pancreatic indication targets roughly 15,000 U.S. patients, expanding Novocure’s oncology portfolio beyond brain cancer.

16-02-2026