MARYLAND / RankWire.AI / – In the United States, the U.S. Food and Drug Administration has given the green light to Rasonque, or daraxonrasib, for certain adult patients battling metastatic pancreatic adenocarcinoma. The approval was finalized on August 26, 2026, providing a new targeted option for patients. This clearance covers adults who have undergone at least one prior systemic treatment and includes those ineligible for multiagent systemic therapy. The medication was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The decision was based on data from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults with metastatic pancreatic adenocarcinoma that had progressed after one systemic therapy line. Researchers randomly assigned 248 patients to receive daraxonrasib, while 252 were given standard chemotherapy selected by their physicians. Results showed a median overall survival of 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Improvements in progression-free survival were also observed across the entire study group. The median progression-free survival was 7.2 months for daraxonrasib versus 3.6 months with standard chemotherapy. The objective response rate was 30% in the daraxonrasib group, compared to 11% in the chemotherapy group. The statistical significance of these differences in overall survival, progression-free survival, and response rate supports the use of the drug in patients whose metastatic disease has already been treated systemically.
Targeted therapy focuses on RAS pathway inhibition
Daraxonrasib functions as a RAS inhibitor, designed to block active RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. Patients take the medication orally at a dose of 300 milligrams once daily, continuing treatment until disease progression or intolerable toxicity occurs. The approval pertains to metastatic pancreatic adenocarcinoma and does not necessitate testing for specific RAS mutations in the intended use.
Safety findings indicated adverse events in all patients who received daraxonrasib during the Phase 3 study. Grade 3 or higher adverse events were observed in 61.8% of the daraxonrasib group and 69.6% of those on chemotherapy. Discontinuation due to treatment-related adverse events was reported in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy group. Common side effects included rash, diarrhea, oral inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also details several serious warnings and precautions.
Expedited review process facilitated by priority programs
Among the warnings are risks of skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also alerts to embryo-fetal toxicity. The FDA reviewed the submission via multiple accelerated oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated it approved the application approximately 6.5 months ahead of its target date. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
The FDA utilized Project Orbis to coordinate the review with other national regulators involved in oncology applications. Health Canada participated in the review, alongside official observers from European and Japanese agencies. The FDA mentioned that other agencies might still be reviewing the application. This approval grants Revolution Medicines the authorization for Rasonque within the specified U.S. patient group. For those with previously treated metastatic pancreatic adenocarcinoma, the key Phase 3 outcome was a median overall survival of 13.2 months compared to 6.7 months with chemotherapy.