USFDAOct 1, 2026, 09:06 AM
NovoCure's Optune Pax® Approved in Japan for Pancreatic Cancer
AI Summary
NovoCure Ltd announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved its Optune Pax® therapy for the treatment of adult patients with unresectable locally advanced pancreatic cancer, when used in combination with gemcitabine and nab-paclitaxel. This approval follows positive results from the Phase 3 PANOVA-3 trial, which demonstrated a statistically significant improvement in overall survival. Optune Pax® had previously received approval from the U.S. Food and Drug Administration and a CE Mark in Europe.
Key Highlights
- NovoCure's Optune Pax® approved by Japan's MHLW for unresectable locally advanced pancreatic cancer.
- Approval is for use concomitant with gemcitabine and nab-paclitaxel.
- Phase 3 PANOVA-3 trial showed statistically significant improvement in overall survival.
- Optune Pax® previously approved by US FDA in February 2026 and received CE Mark in June 2026.
- Pancreatic cancer is a leading cause of cancer death in Japan, with increasing incidence and low survival rates.
- Optune Pax® delivers Tumor Treating Fields (TTFields) non-invasively to disrupt cancer cell division.
Price Impact
More from NVCR