MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, or daraxonrasib, for use in specific adult patients with metastatic pancreatic adenocarcinoma. The FDA announced this decision on August 26, 2026. This approval applies to individuals who have received at least one prior systemic therapy and also includes those who are unable to undergo multiagent systemic treatment. Developed by Revolution Medicines, the oral medication targets the RAS GTPase family, with patients prescribed a dose of 300 milligrams daily.
This approval was based on results from the Phase 3 RASolute 302 trial, which involved 500 adults with metastatic pancreatic adenocarcinoma that had advanced after one previous systemic therapy. Researchers randomized 248 patients to receive daraxonrasib and 252 to a physician-chosen chemotherapy. Median overall survival was 13.2 months for the daraxonrasib group, compared to 6.7 months for those on chemotherapy. The trial demonstrated a hazard ratio for death of 0.40, indicating a significant difference between the two treatments.
In addition to overall survival, daraxonrasib improved several other key endpoints. The median progression-free survival was 7.2 months for patients on daraxonrasib versus 3.6 months on chemotherapy. The objective response rate was 30% for daraxonrasib and 11% for chemotherapy. Statistically significant differences were observed across overall survival, progression-free survival, and response rate, forming the clinical foundation for the FDA’s approval of this therapy in previously treated metastatic pancreatic adenocarcinoma.
Clinical trial findings endorse targeted therapy approval
Daraxonrasib functions by blocking active forms of RAS proteins that promote cancer cell growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not mandate testing for a specific RAS mutation in order to prescribe this drug. The therapy continues until disease progression or intolerable side effects occur. Revolution Medicines created Rasonque as an oral option for this defined patient population, offering a targeted alternative following initial systemic treatments.
The Phase 3 trial also evaluated safety outcomes related to the treatment. Adverse events of Grade 3 or higher occurred in 61.8% of patients receiving daraxonrasib. In comparison, 69.6% of patients on chemotherapy experienced similar severe events. Therapy discontinuation due to adverse events happened in 1.2% of daraxonrasib patients, versus 11.2% in the chemotherapy group. 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 contains warnings for 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. During the evaluation, the FDA employed expedited oncology review programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated that it completed the approval approximately 6.5 months ahead of its regulatory target date.
Furthermore, the FDA reviewed the application through Project Orbis, a program that facilitates collaborative review among international cancer regulators. Health Canada participated in the review process, with European and Japanese regulators serving as official observers. Additionally, daraxonrasib obtained Breakthrough Therapy and Orphan Drug designations in the United States. This approval enables eligible U.S. patients to access Rasonque following previous systemic therapy or if multiagent therapy is unsuitable. The Phase 3 trial demonstrated median overall survival of 13.2 months, compared with 6.7 months for chemotherapy.