MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, specifically for some adult patients with metastatic pancreatic adenocarcinoma. The FDA conveyed its decision on August 26, 2026. This authorization applies to individuals who have undergone at least one prior systemic therapy, as well as those unable to receive multiagent systemic treatments. The oral medication, developed by Revolution Medicines, targets the RAS GTPase family. Patients are advised to take a daily dose of 300 milligrams as recommended.
This approval was based on the Phase 3 RASolute 302 study, which included 500 adults diagnosed with metastatic pancreatic adenocarcinoma. These participants had experienced disease progression following one previous systemic therapy. Researchers randomized 248 patients to receive daraxonrasib, while 252 were assigned to physician-selected chemotherapy. The median overall survival for those on daraxonrasib was 13.2 months, in contrast to 6.7 months for the chemotherapy cohort. The trial also reported a hazard ratio for death of 0.40, indicating a significant difference between the treatment groups.
In addition to improving overall survival, daraxonrasib showed benefits in other key metrics. The median progression-free survival was 7.2 months with daraxonrasib, compared to 3.6 months with chemotherapy. The objective response rate reached 30% in the daraxonrasib group, against 11% in the chemotherapy group. Statistically significant differences were observed across overall survival, progression-free survival, and response rate, providing the core clinical evidence that supported the FDA’s decision to approve the drug for this indication.
Clinical trial outcomes underpin approval for targeted therapy
Daraxonrasib functions by blocking active RAS proteins that promote cancer growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify that patients need to have a particular RAS mutation to qualify for treatment. Therapy continues until disease progression or intolerable side effects occur. Revolution Medicines created Rasonque as an oral option for this specific patient population, providing a targeted alternative after earlier systemic treatments.
Safety assessments from the Phase 3 trial revealed that grade 3 or higher adverse events occurred in 61.8% of patients taking daraxonrasib. In comparison, the rate was 69.6% among those receiving chemotherapy. Treatment-related adverse events led 1.2% of daraxonrasib patients to discontinue therapy, whereas 11.2% of those on chemotherapy did the same. Common adverse effects include 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 lists several 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 utilized expedited oncology review pathways during the evaluation, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that the approval was finalized approximately 6.5 months ahead of its targeted regulatory timeline.
The review process also incorporated Project Orbis, which fosters coordinated regulatory reviews internationally. Health Canada collaborated in the assessment, with European and Japanese regulators participating as official observers. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations within the United States. The approval provides eligible U.S. patients with access to Rasonque after prior systemic therapy or when multiagent therapy is unsuitable. The Phase 3 study demonstrated a median overall survival of 13.2 months, markedly longer than the 6.7 months observed with chemotherapy.