EMA Committee Recommends Approval of Rasonque for Metastatic Pancreatic Cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Revolution Medicines' Rasonque (daraxonrasib). The drug is intended as a monotherapy for adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. If approved by the European Commission, Rasonque would be the first comprehensive RAS-targeted therapy available in the European Union for this aggressive cancer. The recommendation is supported by data from the Phase 3 RASolute 302 trial, which demonstrated a median overall survival of 13.2 months with daraxonrasib compared to 6.7 months with chemotherapy.