approval high confidence

FDA Approves Revolution Medicines' RASONQUE (Daraxonrasib), First Broad RAS-Targeted Medicine for Metastatic Pancreatic Cancer

| Cancer Breakthroughs

The FDA approved RASONQUE (daraxonrasib), Revolution Medicines' oral pan-RAS(ON) multi-selective inhibitor, for adults with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received at least one prior systemic therapy or who are not candidates for multiagent chemotherapy. It is the first targeted cancer medicine ever approved from the RAS(ON) inhibitor class and the first drug to directly target the RAS mutations (predominantly KRAS G12D/G12V) that drive roughly 90% of pancreatic cancers. The approval is based on the Phase 3 RASolute 302 trial, first presented at the ASCO 2026 Plenary Session (June 1, 2026): daraxonrasib extended median overall survival to 13.2 months versus 6.7 months for standard chemotherapy in second-line metastatic PDAC (HR 0.40) — the largest OS benefit ever demonstrated in a Phase 3 trial for this cancer. One oncologist described it as the biggest development in pancreatic cancer treatment in decades.

Revolution Medicines' Redwood City, CA campus, developer of RASONQUE (daraxonrasib), the first FDA-approved pan-RAS(ON) inhibitor for metastatic pancreatic cancer
Revolution Medicines' Redwood City, CA campus, developer of RASONQUE (daraxonrasib), the first FDA-approved pan-RAS(ON) inhibitor for metastatic pancreatic cancer — STAT News