FDA cleared Revolution Medicines’ daraxonrasib (Rasonque), marking the first approved RAS inhibitor for advanced pancreatic ductal adenocarcinoma. The approval supports use in previously treated patients, following a practice-changing Phase 3 program. The pivotal trial data showed a median overall survival of 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy. Revolution’s once-daily oral regimen is designed to target a genetic driver in a disease that has historically seen limited benefit from traditional options. The decision also accelerates commercial expectations for the program and sets a regulatory benchmark for next-generation, mutation-targeted therapies in PDAC.