The FDA approved Revolution Medicines’ oral RAS(ON) inhibitor Rasonque (daraxonrasib) for metastatic pancreatic adenocarcinoma in patients who received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The decision followed the company’s Phase III RASolute 302 results, where daraxonrasib improved median overall survival to 13.2 months versus 6.7 months with investigator’s choice chemotherapy in the intent-to-treat population. The approval came via Priority Review, using Breakthrough Therapy and Orphan Drug designations and the Commissioner’s National Priority Voucher pilot program. Market impact has been mixed: despite the landmark FDA action, Revolution’s shares initially failed to sustain a surge, reflecting investor scrutiny around pricing and sales forecasts even as the regulator moved quickly to authorize a new RAS-directed option.