Revolution Medicines Starts EU Review of Daraxonrasib
Revolution Medicines announced that European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has started a phased review of data on daraxonrasib, the company's investigational RAS multi-selective inhibitor. A phased review aims to accelerate the assessment of a medicine by evaluating the data in phases as they become available, ahead of the submission of a full marketing authorization application. Daraxonrasib was designated by the EMA as an orphan medicinal product for the treatment of pancreatic cancer and has been recognized as a high priority under EMA's Cancer Medicines Pathfinder project based on its potential to address a high unmet medical need. In addition, the company continues to make significant progress on its rolling submission of a new drug application for daraxonrasib to the FDA under the Commissioner's National Priority Voucher pilot program, which is intended to accelerate the development and review of therapies aligned with U.S. national health priorities.
