MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, also known as daraxonrasib, for use in certain adult patients diagnosed with metastatic pancreatic adenocarcinoma. This once-daily oral medication received approval on August 26, 2026, providing a new targeted therapy option for individuals who have already undergone at least one systemic treatment. The approval specifically applies to adults who are either refractory to previous therapies or are unsuitable candidates for multiagent systemic regimens. The drug was developed by Revolution Medicines and functions by targeting the RAS GTPase family.
The decision was based on data from RASolute 302, a Phase 3, randomized, multicenter, open-label trial that enrolled 500 adults with metastatic pancreatic adenocarcinoma that had progressed following one prior systemic therapy. In this study, researchers allocated 248 patients to receive daraxonrasib and 252 to standard chemotherapy selected by their physicians. Results showed a median overall survival of 13.2 months in the daraxonrasib group, compared to 6.7 months among those receiving chemotherapy, with the FDA reporting a hazard ratio for death of 0.40.
The benefits of the drug extended to progression-free survival as well, with median progression-free survival at 7.2 months for patients on daraxonrasib versus 3.6 months for those on standard chemotherapy. The objective response rate was also notably higher in the daraxonrasib cohort at 30%, compared to 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically meaningful, supporting the drug’s use in patients with metastatic disease who have previously required systemic therapy.
Targeted therapy specifically inhibits RAS pathway activity
Daraxonrasib functions as a RAS inhibitor, designed to obstruct active RAS proteins that are responsible for driving tumor growth. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a recommended dose of 300 milligrams once daily, with treatment continuing until there is evidence of disease progression or unacceptable toxicity. The approval does not require the presence of a specific RAS mutation in the tumor for prescribing in metastatic pancreatic adenocarcinoma cases.
Safety data indicated that adverse events occurred in all patients who received daraxonrasib during the Phase 3 trial. Grade 3 or higher adverse events were reported in 61.8% of the daraxonrasib group and 69.6% of those receiving chemotherapy. Treatment discontinuation due to adverse events was observed in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy cohort. Common side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also includes several serious warnings and precautions.
Expedited review pathways facilitated FDA approval
Among the warnings are risks of skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label additionally cautions about embryo-fetal toxicity. The FDA processed the application via multiple accelerated oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, ultimately approving the drug approximately 6.5 months ahead of its scheduled target date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The agency employed Project Orbis for this review, which enabled collaborative evaluation with other national regulators concerning oncology therapies. Health Canada participated in the review process, alongside official observers from European and Japanese regulatory agencies. The FDA stated that applications might still be under review by other authorities. This approval provides Revolution Medicines with its Rasonque authorization for this specific US patient group. The key Phase 3 result for patients with previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months versus 6.7 months with standard chemotherapy, confirming the clinical benefit of the new drug.