MARYLAND / RankWire.AI / – On August 26, 2026, the U.S. Food and Drug Administration authorized Rasonque, also known as daraxonrasib, for specific adult patients battling metastatic pancreatic adenocarcinoma. This approval introduces a new targeted option in the treatment landscape, specifically for those who have already undergone at least one systemic therapy or are ineligible for multiagent systemic approaches. The medication was developed by Revolution Medicines and targets the RAS GTPase family.
The FDA’s green light followed the positive outcomes of RASolute 302, a Phase 3 trial involving 500 adults in a randomized, open-label, multicenter setting. Participants had metastatic pancreatic adenocarcinoma that had advanced after one prior systemic treatment. Researchers allocated 248 patients to receive daraxonrasib and 252 to standard chemotherapy chosen by their physicians. The median overall survival was 13.2 months for those treated with daraxonrasib, compared to 6.7 months for those receiving chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Significant improvements were also observed in progression-free survival among all trial participants. The median was 7.2 months for daraxonrasib versus 3.6 months for standard chemotherapy. The objective response rate reached 30% in the daraxonrasib group, while it was 11% among those on chemotherapy. These differences in overall survival, progression-free survival, and response rate were statistically meaningful, reinforcing the drug’s efficacy for patients with metastatic disease who have previously received systemic treatment.
Targeted therapy focuses on the RAS pathway
Designed to inhibit RAS proteins, daraxonrasib aims to block active RAS forms that promote tumor growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a dose of 300 milligrams once daily, continuing until disease progression or unacceptable toxicity occurs. This approval is specific to metastatic pancreatic adenocarcinoma and does not require a confirmed RAS mutation for prescribing.
In the Phase 3 trial, safety data revealed that all patients experienced adverse events related to daraxonrasib. Grade 3 or higher adverse events affected 61.8% of patients in the daraxonrasib group and 69.6% of those on standard chemotherapy. Treatment-related adverse events led to discontinuation in 1.2% of daraxonrasib patients and 11.2% of chemotherapy patients. Common side effects included rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information contains several warnings and precautions for serious adverse effects.
Accelerated FDA review through priority pathways
Important warnings encompass skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also cautions about embryo-fetal toxicity. The FDA expedited the review process via several programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, and completed the approval approximately 6.5 months ahead of its target date. Daraxonrasib received both Breakthrough Therapy and Orphan Drug designations.
The agency employed Project Orbis for collaborative review with other national regulators in oncology, with Health Canada participating in the process, along with European and Japanese regulators as official observers. The FDA noted that other agencies might still be reviewing applications. The approval grants Revolution Medicines its authorization for Rasonque in the U.S. for this patient group. The primary Phase 3 trial outcome for previously treated metastatic pancreatic adenocarcinoma demonstrated a median overall survival of 13.2 months compared to 6.7 months with chemotherapy.