MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for specific adult patients with metastatic pancreatic adenocarcinoma. On August 26, 2026, the FDA authorized the use of this once-daily tablet, providing a new targeted therapeutic option for patients. The authorization applies to adults who have previously undergone at least one systemic therapy and includes those who are ineligible for multiagent systemic treatment. Developed by Revolution Medicines, the drug specifically targets the RAS GTPase family.
This approval is based on data from RASolute 302, a randomized, open-label, multicenter Phase 3 trial involving 500 adult participants. All had metastatic pancreatic adenocarcinoma that had advanced after one prior systemic therapy. Researchers assigned 248 patients to receive daraxonrasib and 252 to receive standard chemotherapy selected by their physicians. The median overall survival was 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Additionally, progression-free survival saw significant improvement across the entire study population. Patients on daraxonrasib experienced a median progression-free survival of 7.2 months versus 3.6 months for those on standard chemotherapy. The objective response rate was 30% for the daraxonrasib group and 11% for the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically meaningful. The findings endorse the drug’s use in patients whose metastatic disease has already necessitated systemic therapy.
Targeted medication interferes with RAS signaling pathway
Daraxonrasib functions as a RAS inhibitor, engineered to block active forms of RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a dose of 300 milligrams once per day, continued until disease progression or intolerable adverse effects occur. The approval encompasses metastatic pancreatic adenocarcinoma without requiring a specific RAS mutation for prescribing.
Safety analyses indicated that all patients treated with daraxonrasib experienced adverse events during the Phase 3 trial. Grade 3 or higher adverse events were observed in 61.8% of those on daraxonrasib and 69.6% on chemotherapy. Discontinuation due to treatment-related adverse events happened in 1.2% of daraxonrasib patients versus 11.2% in the chemotherapy group. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information highlights several serious warnings and precautions.
Fast-tracked FDA review process
These warnings cover skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also alerts to embryo-fetal toxicity. The FDA expedited the review of this application through multiple oncology-focused programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that approval was granted approximately 6.5 months ahead of its scheduled target date. Daraxonrasib also earned Breakthrough Therapy and Orphan Drug designations.
The review involved Project Orbis, enabling collaboration with other international regulators on oncology submissions. Health Canada participated in the review, while European and Japanese agencies served as official observers. The FDA noted that applications may still be under review elsewhere. This approval grants Revolution Medicines the authorization to market Rasonque for the specified U.S. patient group. For patients with previously treated metastatic pancreatic adenocarcinoma, the key Phase 3 finding was a median overall survival of 13.2 months compared to 6.7 months with standard chemotherapy.