Revolution Medicines Wins EU Advisory Panel Backing for Pancreatic Cancer Drug Daraxonrasib

Revolution Medicines received a positive opinion from the European Medicines Agency's Committee for Human Medicinal Products on Thursday, recommending marketing authorization in the European Union for daraxonrasib, sold under the brand name RASONQUE, for the treatment of metastatic pancreatic cancer. The CHMP opinion is the final step before the European Commission grants formal approval, which typically follows within weeks and would make the drug available to patients across all 27 EU member states.

Daraxonrasib is an oral RAS(ON) multi-selective inhibitor developed to address a form of cancer with extremely poor prognosis. Patients with metastatic pancreatic cancer whose disease has progressed after prior treatment have very limited options and a median life expectancy of roughly six months, making the drug's development a response to a significant unmet medical need. The EMA had granted daraxonrasib Orphan Drug Designation in April 2026 and initiated an accelerated phased review of the drug in July 2026 under its Cancer Medicines Pathfinder project, reflecting the urgency of getting the therapy to patients.

The EU recommendation follows a busy regulatory period for Revolution Medicines. The U.S. FDA accepted the company's New Drug Application for daraxonrasib for review earlier this year, based on Phase 3 results from the RASolute-302 trial, which compared the drug against chemotherapy in previously treated metastatic pancreatic cancer patients. Revolution Medicines also has ongoing Phase 3 studies evaluating daraxonrasib in earlier-stage settings, including adjuvant and first-line metastatic disease.