Revolution Medicines said the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending RASONQUE (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy.
The recommendation is based on the pivotal Phase 3 RASolute 302 trial, in which RASONQUE significantly improved survival compared with chemotherapy. Median overall survival was 13.2 months with RASONQUE, versus 6.7 months with chemotherapy.
The positive opinion followed an expedited review. The European Commission will make the final marketing authorization decision.
The U.S. FDA approved the drug in August 2026.