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CHMP Recommends Approval of Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer
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Fusion42 · 15 October 2026 · Fusion42 review
The EMA's CHMP has recommended marketing authorization for daraxonrasib as a monotherapy for adults with metastatic pancreatic adenocarcinoma after prior systemic therapy, based on phase 3 trial data showing significant improvements in overall and progression-free survival. The European Commission will now decide on centralized approval across the EU and associated countries.
This Wire brief sits within Fusion42's coverage of Biotech, and 2 sources have reported it between 15 Oct 2026 and 17 Oct 2026.
◆ ◆ The Wire takeaway
You now face an opening in Europe to develop or sell therapies targeting RAS mutations in pancreatic cancer as daraxonrasib nears EU approval, shifting pancreatic cancer treatment beyond chemotherapy alone. Drug developers focused on RAS inhibitors should accelerate plans for European market entry to capture this expanding opportunity.
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2 sources · first reported 15 Oct 2026 · latest 17 Oct 2026
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