FDA Authorizes Expanded Access to Daraxonrasib After Unprecedented Phase 3 Survival Data in Pancreatic Cancer

The FDA authorized Revolution Medicines to proceed with an Expanded Access Program (EAP) for daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The authorization came within 48 hours of the April 28 submission, reflecting urgency driven by Phase 3 RASolute 302 results: daraxonrasib extended median overall survival to 13.2 months versus 6.7 months for standard chemotherapy — a 60% reduction in the risk of death (HR 0.40). Oncologists widely described the results as 'unprecedented' for metastatic pancreatic cancer, a disease with historical 5-year survival of ~13% and a median OS of 6–7 months on second-line chemotherapy. Over 90% of pancreatic cancers harbor RAS mutations (predominantly KRAS G12X), making RAS inhibition a scientifically rational strategy for the majority of patients. The EAP allows access before the New Drug Application (NDA) is filed. Full Phase 3 data are scheduled for plenary presentation at the ASCO Annual Meeting on May 31, 2026, alongside a planned regulatory submission.