The U.S. Food and Drug Administration (FDA) recently approved daraxonrasib, (Rasonque), a multiselective RAS(ON) inhibitor, for treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
Brian M. Wolpin, MD, MPH
Approval of the drug was based on data from the phase III RASolute 302 trial presented by Brian M. Wolpin, MD, MPH, Director of the Hale Family Center for Pancreatic Cancer Research and the Gastrointestinal Cancer Center, Dana-Farber Cancer Institute, Boston during the Plenary Session at the 2026 ASCO Annual Meeting.1 The data were published simultaneously by O’Reilly et al in The New England Journal of Medicine.2
Results Are ‘Unprecedented’
In the phase III trial, median overall survival was nearly doubled among patients with previously treated metastatic pancreatic cancer who received daraxonrasib.
“This drug showed unprecedented results in an area of high unmet need,” said R. Angelo de Claro, MD, Director of the FDA’s Oncology Center of Excellence. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”
R. Angelo de Claro, MD
Approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the United States each year are pancreatic adenocarcinoma, according to the National Cancer Institute. Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options.
Daraxonrasib is an oral agent taken once daily, targeting multiple forms of RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma. The most common side effects of the drug are rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage.
The FDA granted daraxonrasib Breakthrough Therapy and Orphan Drug designations. Daraxonrasib received Priority Review for this indication. The application was also reviewed under the Commissioner’s National Priority Voucher pilot program, which is intended to help accelerate the review of therapies that address national public health priorities.
The FDA granted the approval to Revolution Medicines, Inc.
REFERENCES
1. Wolpin BM, Wainberg ZA, Hendifar A, et al: Daraxonrasib, a RAS(ON) multi-selective inhibitor vs chemotherapy in previously treated metastatic pancreatic adenocarcinoma (mPDAC): Primary and final analysis from the phase 3 RASolute 302 study. 2026 ASCO Annual Meeting. Abstract LBA5. Presented May 31, 2026.
2. O’Reilly EM, Wainberg ZA, Hendifar AE, et al: Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med 395:325-337, 2026 (published online May 31, 2026).
