Aug. 26, 2026—The Food and Drug Administration today approved daraxonrasib (Rasonque, Revolution Medicines) for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. Rasonque, a tablet taken once daily, targets multiple forms of the RAS protein, a key driver of tumor growth in most patients with pancreatic adenocarcinoma.
In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared with 6.7 months for standard chemotherapy.
“This drug showed unprecedented results in an area of high unmet need,” Angelo de Claro, MD, director of the FDA’s Oncology Center of Excellence, said in an FDA news release.
Rasonque was granted FDA breakthrough therapy and orphan drug designations and received priority review for this indication.