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, with the agency announcing this decision on August 26, 2026. This approval applies to patients who have previously undergone at least one systemic therapy and includes those who are unable to receive multiagent systemic treatments. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family, with the prescribed dose recommended at 300 milligrams once every day.
The regulatory decision was based on data from the Phase 3 RASolute 302 trial, which involved 500 adults with metastatic pancreatic adenocarcinoma that had advanced following one prior systemic treatment. Participants were assigned to either daraxonrasib (248 patients) or physician-selected chemotherapy (252 patients). Results showed a median overall survival of 13.2 months for those taking daraxonrasib, compared to 6.7 months for patients on chemotherapy. 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 superiority across other key endpoints. Median progression-free survival was 7.2 months with daraxonrasib versus 3.6 months with chemotherapy. The objective response rate was 30% for daraxonrasib, while chemotherapy achieved 11%. The data revealed statistically meaningful differences in overall survival, progression-free survival, and response rate, serving as the principal clinical evidence supporting the U.S. approval for this treatment in previously treated metastatic pancreatic adenocarcinoma.
Clinical trial outcomes underpin targeted therapy authorization
Daraxonrasib functions by inhibiting active forms of RAS proteins that can promote cancer cell growth, with RAS mutations present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information, however, does not specify that patients must harbor a particular RAS mutation to be eligible for this treatment. Patients continue therapy until their cancer progresses or adverse effects become intolerable. Revolution Medicines designed Rasonque as an oral agent tailored for this specific patient population, providing a targeted option after initial systemic treatments have been administered.
The Phase 3 trial also evaluated safety outcomes related to the treatment. Grade 3 or higher adverse events were observed in 61.8% of patients treated with daraxonrasib, compared to 69.6% in the chemotherapy group. Treatment discontinuation due to adverse events occurred in 1.2% of daraxonrasib recipients, whereas 11.2% of those receiving chemotherapy stopped treatment for similar reasons. Common adverse effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
International collaboration influenced FDA review process
The prescribing information for Rasonque contains warnings for several severe risks, including skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA employed expedited review pathways for oncology drugs during the evaluation process, such as the Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, completing the approval approximately 6.5 months before the agency’s standard deadline.
Furthermore, the agency reviewed the application through Project Orbis, which promotes coordinated assessment among international cancer regulators. Health Canada participated in the review, alongside official observers from European and Japanese regulators. In addition, daraxonrasib received Breakthrough Therapy and Orphan Drug designations within the United States. This approval offers eligible U.S. patients access to Rasonque following prior systemic therapy or when multiagent therapy is unsuitable, with the Phase 3 trial demonstrating a median overall survival of 13.2 months compared with 6.7 months for chemotherapy.