RevMed’s pancreatic cancer drug gets expedited European review
What Happened
The European Medicines Agency’s CHMP has started a phased review of daraxonrasib, Revolution Medicines’ RAS-targeted drug for pancreatic cancer. The phased process allows regulators to assess data as it becomes available before a full marketing-authorisation application is submitted. The drug has also received orphan medicinal product designation for pancreatic cancer and was recognised as a high priority under the EMA’s Cancer Medicines Pathfinder project.
Key Takeaways
The development could accelerate the European assessment of daraxonrasib, but it should not yet be described as European approval based on the EMA-related information I could verify. Separately, the drug received US FDA approval on August 26, 2026 for certain patients with metastatic pancreatic cancer.