The FDA approved Revolution Medicines’ oral RAS(ON) inhibitor daraxonrasib (Rasonque) for metastatic pancreatic ductal adenocarcinoma (PDAC) in a new label aimed at patients who received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The decision follows FDA Priority Review and reflects Phase 3 RASolute 302 data, which showed a median overall survival of 13.2 months versus 6.7 months with investigator’s-choice chemotherapy in the overall intent-to-treat population. The trial also reported median progression-free survival of 7.3 months versus 3.5 months and a confirmed overall response rate of 33.2% versus 11.8%. The approval was supported by Breakthrough Therapy and Orphan Drug designations and accelerated by the agency’s Commissioner’s National Priority Voucher pilot program, shortening the typical review timeline. Revolution’s stock reaction in the provided coverage highlighted investor debate over pricing and near-term sales expectations. For biotech stakeholders, the action signals continued regulatory appetite for targeted RAS-pathway therapies in PDAC, where treatment options have remained limited relative to other solid tumors.