MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration approved Rasonque, or daraxonrasib, for certain adults with metastatic pancreatic adenocarcinoma. The FDA announced the decision on August 26, 2026. The approval covers patients who received at least one previous systemic therapy. It also includes adults who cannot receive multiagent systemic therapy. Revolution Medicines developed the oral treatment, which targets the RAS GTPase family. Patients take the medicine at a recommended dose of 300 milligrams once daily.
The decision followed the Phase 3 RASolute 302 trial, which enrolled 500 adults with metastatic pancreatic adenocarcinoma. Their cancer had progressed after one previous line of systemic therapy. Researchers assigned 248 patients to daraxonrasib and 252 to physician-selected chemotherapy. Median overall survival reached 13.2 months with daraxonrasib. Patients receiving chemotherapy had median overall survival of 6.7 months. The trial reported a hazard ratio for death of 0.40, showing a clear difference between the treatment groups.
Daraxonrasib also improved other major measures in the study. Median progression-free survival reached 7.2 months in the daraxonrasib group. The chemotherapy group recorded 3.6 months. The objective response rate was 30% with daraxonrasib and 11% with chemotherapy. Researchers found statistically significant differences in overall survival, progression-free survival and response rate. These results formed the main clinical evidence behind the U.S. approval for previously treated metastatic pancreatic adenocarcinoma.
Trial results support targeted treatment approval
Daraxonrasib works by inhibiting active forms of RAS proteins that can drive cancer growth. RAS mutations occur in more than 90% of pancreatic ductal adenocarcinomas. The prescribing information does not require patients to have a specific RAS mutation for this indication. Treatment continues until the cancer progresses or side effects become unacceptable. Revolution Medicines developed Rasonque as an oral medicine for this defined patient group, adding a targeted option after earlier systemic treatment.
The Phase 3 trial also measured treatment-related safety outcomes. Grade 3 or higher adverse events occurred in 61.8% of patients receiving daraxonrasib. The rate reached 69.6% among patients receiving chemotherapy. Treatment-related adverse events led 1.2% of daraxonrasib patients to stop therapy, compared with 11.2% in the chemotherapy group. Common side effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, reduced appetite, edema, mouth inflammation and bleeding.
FDA review included international regulatory cooperation
The Rasonque prescribing information carries warnings for several serious risks. These include skin and soft tissue toxicity, oral disorders, severe diarrhea and gastrointestinal perforation. It also lists interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA used expedited oncology review programs when evaluating the application. Those included Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency said it completed the approval about 6.5 months before its regulatory goal date.
The FDA also reviewed the application through Project Orbis, which supports coordinated work among international cancer regulators. Health Canada collaborated in the review. European and Japanese regulators participated as official observers. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations in the United States. The approval gives eligible U.S. patients access to Rasonque after previous systemic therapy or when multiagent therapy is unsuitable. Its Phase 3 trial showed median overall survival of 13.2 months, compared with 6.7 months for chemotherapy.