Novocure wins FDA approval for pancreatic cancer treatment.

The FDA approved Novocure's Optune Pax for certain locally advanced pancreatic cancers after a Phase 3 trial met its primary endpoint; the company's shares rose in after-hours trading.

The Food and Drug Administration approved Novocure's Optune Pax to treat certain locally advanced pancreatic cancers. The approval covers use in adult patients alongside the chemotherapy agents gemcitabine and nab-paclitaxel, the company announced. The decision follows a Phase 3 trial that met its primary endpoint showing a statistically significant improvement in median overall survival. Key facts: - The FDA granted approval for Optune Pax for specified locally advanced pancreatic cancer patients. - The indicated use is in adults in combination with gemcitabine and nab-paclitaxel. - Approval was based on a Phase 3 trial that met its primary endpoint with improved median overall survival. - The article reports the company's shares rose about 53% in after-hours trading following the announcement. Summary: The approval adds a new, approved option for the defined patient group after positive late-stage trial results. Market trading reacted strongly to the announcement. Undetermined at this time.