Signal FDA Approves First Broad RAS-Targeted Drug for Metastatic Pancreatic Cancer

Summary

The FDA approved Revolution Medicines' daraxonrasib, branded RASONQUE, on August 26, 2026, marking the first broad RAS-targeted medicine approved for metastatic pancreatic cancer. Approval was based on data from RASolute 302, a global randomized Phase 3 trial comparing daraxonrasib against investigator's-choice cytotoxic chemotherapy. Pancreatic cancer has one of the highest rates of RAS gene mutation among solid tumors, yet no RAS-directed therapy had previously been approved for the disease. The approval extends the class of RAS/KRAS inhibitors, which had previously seen clinical success mainly in lung and colorectal cancers, into a new and historically difficult-to-treat indication. The announcement was issued by developer Revolution Medicines via press release.