Revolution Medicines’ Pancreatic Cancer Drug Wins Fast FDA Approval for Expanded Access

The U.S. Food and Drug Administration has granted Revolution Medicines permission to begin an expanded access program for daraxonrasib, an investigational treatment for previously treated metastatic pancreatic ductal adenocarcinoma. The agency issued its “safe to proceed” letter just two days after receiving the company’s request. In a Phase 3 trial, patients receiving the once-daily drug had median overall survival of 13.2 months, compared with 6.7 months for those receiving chemotherapy. Daraxonrasib is not yet fully FDA-approved, and access requires a request from an eligible patient’s physician.