MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration granted approval to Rasonque, also known as daraxonrasib, for use in specific adult patients with metastatic pancreatic adenocarcinoma. The agency announced this decision on August 26, 2026. This approval applies to individuals who have received at least one prior systemic therapy and also extends to adults who are ineligible for multiagent systemic treatment. Revolution Medicines developed this oral medication, which targets the RAS GTPase family. Patients are advised to take a daily dose of 300 milligrams of the drug.
The approval was based on results from the Phase 3 RASolute 302 trial, involving 500 adults with metastatic pancreatic adenocarcinoma. Participants’ cancer had advanced following one prior systemic treatment. Researchers allocated 248 patients to receive daraxonrasib, while 252 were assigned to the investigator’s choice of chemotherapy. The median overall survival was 13.2 months with daraxonrasib, compared to 6.7 months for those on chemotherapy. The trial reported a hazard ratio for death of 0.40, indicating a significant benefit for the drug group.
Additional key outcomes demonstrated the efficacy of daraxonrasib. Median progression-free survival was 7.2 months in the daraxonrasib cohort versus 3.6 months among chemotherapy recipients. The objective response rate stood at 30% with daraxonrasib, in contrast to 11% with chemotherapy. Statistically significant differences emerged in overall survival, progression-free survival, and response rate. These findings formed the core clinical evidence supporting the U.S. approval for previously treated metastatic pancreatic adenocarcinoma.
Clinical data underpins targeted therapy approval
Daraxonrasib functions by blocking active RAS proteins that can promote tumor growth. RAS mutations 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 is continued until the disease progresses or side effects become intolerable. Revolution Medicines designed Rasonque as an oral treatment option for this specific patient group, offering a targeted therapy after initial systemic treatments.
The Phase 3 trial also evaluated safety outcomes related to the treatment. Grade 3 or higher adverse events occurred in 61.8% of patients taking daraxonrasib, compared to 69.6% among those receiving chemotherapy. Treatment-related adverse events led 1.2% of daraxonrasib patients to discontinue therapy, whereas 11.2% of chemotherapy patients did so. Common side 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 includes warnings about several serious risks. These encompass skin and soft tissue toxicity, oral issues, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA utilized expedited oncology review pathways during its assessment, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency indicated it finalized approval approximately 6.5 months before the targeted regulatory timeline.
Furthermore, the FDA evaluated the application through Project Orbis, which promotes coordinated review among international cancer regulators. Health Canada participated in the review process. Regulatory agencies from Europe and Japan observed as official reviewers. In addition, daraxonrasib received Breakthrough Therapy and Orphan Drug designations in the United States. This approval grants eligible U.S. patients access to Rasonque after prior systemic therapy or if multiagent approaches are unsuitable. Its Phase 3 trial demonstrated a median overall survival of 13.2 months, compared to 6.7 months with chemotherapy.
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