On October 19, 2026, the U.S. Food and Drug Administration (FDA) approved Rasonque (daraxonrasib), an oral RAS inhibitor from Revolution Medicines, Inc., for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.
The approval is based on a randomized, open-label, multicenter trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma. Participants received once-daily oral daraxonrasib or standard chemotherapy. The trial showed a median overall survival of 13.2 months with daraxonrasib versus 6.7 months with standard chemotherapy.
Daraxonrasib targets multiple forms of the RAS protein, a key driver of tumor growth in most pancreatic adenocarcinomas, and the approved indication does not impose a biomarker-based eligibility criterion. The approval offers a new treatment option for pancreatic cancer patients, who have historically faced limited treatment choices and poor outcomes.
The most common side effects reported with daraxonrasib included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.
The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations and Priority Review, and the application was reviewed through the Commissioner's National Priority Voucher pilot program. Approval came 6.5 months ahead of the user-fee deadline.

Source: https://reachmd.com/news/fda-approves-daraxonrasib-for-metastatic-pancreatic-cancer/2488736/