FDA Approves Revolution Medicines Rasonque (Daraxonrasib) for Metastatic Pancreatic Adenocarcinoma
The FDA on Wednesday August 26, 2026 approved Rasonque (daraxonrasib, a once-daily oral pan-RAS inhibitor developed by Revolution Medicines) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-agent chemotherapy. Approval was based on the Phase 3 RASolute 302 trial across 500 previously-treated patients showing median overall survival of 13.2 months on Rasonque versus 6.7 months on standard chemotherapy. The drug does not require a companion diagnostic and is approved for patients with or without an identifiable RAS tumor mutation. FDA granted Breakthrough Therapy and Orphan Drug designations plus Priority Review. Daraxonrasib is a small molecule and not a peptide; the approval matters to peptide-relevant readers because it hardens the oncology backdrop the neoantigen peptide vaccine class (Merck-Moderna intismeran, individualized long-peptide programs) is entering, and because it validates a new mechanism class in a tumor where five-year survival has stalled near 13% for two decades.