The FDA approved Revolution Medicines’ oral therapy Rasonque (daraxonrasib), the first RAS inhibitor authorized for the treatment of metastatic pancreatic ductal adenocarcinoma in appropriate patients. The approval follows the company’s RASolute 302 phase 3 trial results, which showed median overall survival of 13.2 months in the intent-to-treat population versus 6.7 months with standard-of-care chemotherapy. Revolution received a Priority Review and Breakthrough Therapy and Orphan Drug designations, and the agency granted additional speed via the Commissioner’s National Priority Voucher pilot program. The approval is aimed at adults with metastatic PDAC who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Even with the regulatory milestone, market reaction appeared muted in the week surrounding approval, highlighting ongoing investor focus on pricing and long-term sales expectations for targeted oncology agents.