Revolution Medicines (Nasdaq: RVMD) revealed that the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP)has initiated a phased review of daraxonrasib (RMC-6236) for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The company also said its rolling New Drug Application to the US FDA is nearing completion, marking the first global regulatory filings for a RAS(ON) multi-selective inhibitor.
The rolling NDA submission to the US FDA is being conducted under the Commissioner's National Priority Voucher pilot program, which is intended to accelerate development and review of therapies aligned with US national health priorities. Daraxonrasib also holds FDA Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic PDAC harboring G12 mutations. In Europe, the drug has been designated an orphan medicinal product for pancreatic cancer and recognized as a high priority under the EMA's Cancer Medicines Pathfinder project. The EMA's phased review mechanism is designed to accelerate assessment by evaluating evidence in stages ahead of a full marketing authorization application.
The filings are supported by the Phase III RASolute 302 trial, in which daraxonrasib significantly improved overall survival, progression-free survival, and objective response rate compared with chemotherapy while demonstrating a lower rate of grade ≥3 treatment-related adverse events. Full results were presented at the 2026 ASCO Annual Meeting plenary session and published simultaneously in The New England Journal of Medicine.