Revolution Medicines' Daraxonrasib Gets EMA Phased Review; FDA NDA Nears Completion

Revolution Medicines announced that the European Medicines Agency (EMA) has initiated a phased review of its investigational drug, daraxonrasib, for pancreatic cancer, aiming to accelerate its assessment. This follows the drug's designation as an orphan medicinal product and high priority under EMA’s Cancer Medicines Pathfinder. Concurrently, the company is nearing completion of its rolling New Drug Application (NDA) submission to the U.S. FDA under the Commissioner’s National Priority Voucher pilot program. These regulatory advancements are supported by positive Phase 3 RASolute 302 trial results, which demonstrated improved overall and progression-free survival.