MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, or daraxonrasib, as a treatment option for certain adults with metastatic pancreatic adenocarcinoma. The agency approved the once-daily oral tablet on August 26, 2026, expanding options for patients. This approval covers adults who have undergone at least one systemic therapy and those ineligible for multiagent treatments. Revolution Medicines developed the medication, which targets the RAS GTPase family.
The decision was based on data from RASolute 302, a Phase 3, randomized, open-label, multicenter trial involving 500 adults. All participants had metastatic pancreatic adenocarcinoma that progressed after one prior systemic treatment. Researchers assigned 248 patients to daraxonrasib and 252 to physician-chosen standard chemotherapy. The median overall survival was 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy, with the FDA noting a hazard ratio for death of 0.40.
Progression-free survival also showed improvement. Median progression-free survival was 7.2 months for those on daraxonrasib versus 3.6 months with standard chemotherapy. The objective response rate stood at 30% for the daraxonrasib group and 11% for the chemotherapy group. The statistically significant differences in overall survival, progression-free survival, and response rate support the drug’s use in patients with metastatic disease needing systemic treatment.
Targeted therapy inhibits RAS signaling pathway
Daraxonrasib functions as a RAS inhibitor designed to block active RAS proteins that promote tumor growth. Since RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas, the oral medication is prescribed at a dose of 300 milligrams daily, continuing until disease progression or intolerable side effects. The FDA’s approval encompasses metastatic pancreatic adenocarcinoma without requiring a specific RAS mutation for treatment eligibility.
Safety results indicated that all patients on daraxonrasib experienced adverse events. Grade 3 or higher adverse events occurred in 61.8% of the daraxonrasib group and 69.6% of those on chemotherapy. Treatment-related adverse events led to discontinuation in 1.2% of daraxonrasib patients and 11.2% of chemotherapy patients. Common side effects include rash, diarrhea, oral inflammation, nausea, fatigue, vomiting, abdominal pain, edema, loss of appetite, and bleeding, with additional warnings and precautions listed in the prescribing information.
Regulatory review expedited through priority pathways
The FDA highlighted warnings such as skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Embryo-fetal toxicity is also noted. The agency accelerated review via programs like Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, approving the application approximately 6.5 months ahead of schedule. Daraxonrasib received both Breakthrough Therapy and Orphan Drug designations.
The application was evaluated through Project Orbis, enabling collaboration with other regulatory agencies on oncology drugs. Health Canada participated in the review, along with Japanese and European regulators as observers. The FDA noted other agencies may still be reviewing the drug. This approval grants Revolution Medicines the Rasonque label for the specified U.S. patient group. The key Phase 3 result for previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months versus 6.7 months with chemotherapy.