MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, also known as daraxonrasib, for use in certain adults diagnosed with metastatic pancreatic adenocarcinoma. The agency announced this decision on August 26, 2026. This approval applies to patients who have previously undergone at least one systemic therapy, including those unable to receive multiagent systemic treatments. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family. Patients are advised to take the drug at a dose of 300 milligrams once daily as recommended.
The approval followed results from the Phase 3 RASolute 302 study, which involved 500 adults with metastatic pancreatic adenocarcinoma. All participants’ cancers had progressed after one prior systemic treatment. Researchers randomized 248 patients to receive daraxonrasib and 252 to physician-chosen chemotherapy. The median overall survival was 13.2 months with daraxonrasib, whereas those on chemotherapy had a median survival of 6.7 months. The study reported a hazard ratio for death of 0.40, indicating a significant difference between the two groups.
In addition to improving overall survival, daraxonrasib demonstrated benefits in other critical measures. Median progression-free survival was 7.2 months for the daraxonrasib cohort, compared to 3.6 months in the chemotherapy group. The objective response rate was 30% with daraxonrasib versus 11% with chemotherapy. Statistically significant differences were observed across overall survival, progression-free survival, and response rate, providing key clinical evidence that supported the FDA’s approval for patients with metastatic pancreatic adenocarcinoma who had prior treatments.
Clinical trial results underpin targeted therapy approval
Daraxonrasib functions by inhibiting active RAS proteins that promote cancer cell growth. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not require patients to have a specific RAS mutation for this indication. The treatment continues until disease progression or intolerable side effects occur. Revolution Medicines designed Rasonque as an oral therapy aimed at this specific patient group, adding a targeted option following earlier systemic treatments.
Safety was also assessed in the Phase 3 trial, with 61.8% of patients on daraxonrasib experiencing Grade 3 or higher adverse events. Among chemotherapy recipients, this rate was 69.6%. Treatment discontinuation due to adverse events occurred in 1.2% of patients taking daraxonrasib, compared to 11.2% in the chemotherapy group. Common adverse effects included rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
International cooperation influenced FDA review process
The prescribing information for Rasonque includes warnings for multiple serious risks, such as skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA expedited the review process using oncology-specific programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency completed the approval approximately 6.5 months before its typical regulatory timeline.
Furthermore, the FDA’s review incorporated international cooperation through Project Orbis, which promotes coordinated evaluation among global cancer regulatory agencies. Health Canada participated in the review, with European and Japanese regulators serving as official observers. In the United States, daraxonrasib also received Breakthrough Therapy and Orphan Drug designations. The approval grants eligible U.S. patients access to Rasonque after previous systemic therapy or if multiagent treatment is unsuitable. The Phase 3 trial demonstrated a median overall survival of 13.2 months, compared to 6.7 months with chemotherapy.