FDA approved Rasonque (daraxonrasib) for metastatic pancreatic adenocarcinoma, delivering a new treatment option months ahead of schedule. Pancreatic adenocarcinoma accounts for 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed in the United States each year and represents about 3.2% of all cancer diagnoses, contributing disproportionately to cancer deaths. In a multicenter, open‑label trial of 500 adults with previously treated metastatic disease, Rasonque extended median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy. The indication covers adults with metastatic disease who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. The FDA granted Breakthrough Therapy and Orphan Drug designations, gave Priority Review, and used a National Priority Voucher pilot program to accelerate the review, approving the drug 6.5 months before the user fee deadline. The most common adverse events were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage. The approval was granted to Revolution Medicines, Inc. Acting FDA Commissioner Kyle Diamantas said the approval provides a critical new option for patients with an historically difficult cancer and reflects the agency’s commitment to speed innovative treatments. Angelo de Claro, director of the FDA Oncology Center of Excellence, said the drug showed unprecedented results in an area of high unmet need.