regulatory
confidence high
sentiment positive
materiality 0.85
FDA Approves Novocure's Optune Pax for Locally Advanced Pancreatic Cancer
NovoCure Ltd
- FDA approval based on Phase 3 PANOVA-3 trial in 571 patients with locally advanced pancreatic cancer.
- Median overall survival improved to 16.2 months vs 14.2 months (HR 0.82, p=0.039).
- Time to pain progression extended by 6.1 months (15.2 vs 9.1 months).
- First new treatment approved for locally advanced pancreatic cancer in nearly 30 years.
- Optune Pax well-tolerated; most adverse events were mild-to-moderate skin reactions under arrays.
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