EMA phased review of daraxonrasib

Revolution Medicines announced that the European Union — European Medicines Agency's European Union — Committee for Medicinal Products for Human Use has started a phased review of daraxonrasib, an investigational RAS(ON) multi-selective inhibitor for pancreatic cancer. The phased review aims to accelerate assessment ahead of a full marketing authorization application. Daraxonrasib was designated as an orphan medicinal product and recognized under EMA's Cancer Medicines Pathfinder project. Concurrently, Revolution Medicines is nearing completion of a rolling New Drug Application submission to the U.S. FDA under the Commissioner's National Priority Voucher pilot program. The regulatory progress is supported by positive Phase 3 RASolute 302 trial results showing unprecedented survival improvements.