FDA Approves Rasonque for Metastatic Pancreatic Cancer

The FDA approved daraxonrasib (Rasonque) as a first-in-class RAS inhibitor for adults with metastatic pancreatic ductal adenocarcinoma who have received at least one prior systemic therapy or are ineligible for multiagent therapy. The approval was driven by the Phase 3 RASolute 302 trial, which showed a median overall survival of 13.2 months versus 6.7 months with chemotherapy and a notable improvement in progression-free survival. RevMed targets multiple RAS isoforms, addressing a driver mutation in the majority of pancreatic cancers, and pursued accelerated review with an accompanying early access program. Regulators noted the approval was granted well ahead of deadlines, reflecting a rapid regulatory path for a high-need indication. Side effects include rash and mouth sores, and price details have not yet been disclosed. The development signals potential for broader trials in earlier disease stages and a larger patient population.