MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, for specific adult patients with metastatic pancreatic adenocarcinoma. The FDA announced this decision on August 26, 2026. It covers patients who have undergone at least one prior systemic therapy and those who are ineligible for multiagent systemic treatment. Developed by Revolution Medicines, this oral medication targets the RAS GTPase family. Patients are advised to take 300 milligrams of the drug once daily.
This approval was based on findings from the Phase 3 RASolute 302 trial, which involved 500 adults with metastatic pancreatic adenocarcinoma that had advanced after a single systemic therapy. Participants were randomized to receive either daraxonrasib (248 patients) or physician-chosen chemotherapy (252 patients). The median overall survival was 13.2 months for those on daraxonrasib, compared to 6.7 months for chemotherapy recipients. The trial reported a hazard ratio for death of 0.40, indicating a significant advantage for the targeted treatment.
Daraxonrasib also demonstrated improvements in other key endpoints. Median progression-free survival reached 7.2 months with daraxonrasib versus 3.6 months with chemotherapy. The objective response rate was 30% in the daraxonrasib group and 11% in the chemotherapy group. Statistically significant differences were observed across overall survival, progression-free survival, and response rate metrics, forming the basis for the FDA’s approval for patients with previously treated metastatic pancreatic adenocarcinoma.
Clinical trial outcomes bolster the case for targeted therapy approval
Daraxonrasib functions by inhibiting active forms of RAS proteins that promote cancer progression. RAS mutations are found in over 90% of pancreatic ductal adenocarcinomas. The prescribing details do not require patients to have a specific RAS mutation for this indication. Treatment continues until disease progression or intolerable side effects occur. Revolution Medicines developed Rasonque as an oral therapy for this defined patient group, providing a new targeted option following initial systemic treatments.
The Phase 3 trial also assessed safety. Grade 3 or higher adverse events appeared in 61.8% of daraxonrasib patients, compared to 69.6% in those receiving chemotherapy. Treatment discontinuation due to adverse events was lower in the daraxonrasib group (1.2%) versus the chemotherapy group (11.2%). Common side effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, reduced appetite, edema, mouth inflammation, and bleeding.
International cooperation marked the FDA review process
The prescribing information for Rasonque includes warnings for serious risks such as skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA utilized expedited review programs like Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency finalized approval approximately 6.5 months ahead of its regulatory target date.
The FDA also evaluated the application through Project Orbis, which promotes coordinated reviews among global cancer regulatory agencies. Health Canada participated in the process, with European and Japanese regulators serving as official observers. In the U.S., daraxonrasib received Breakthrough Therapy and Orphan Drug designations. This approval allows eligible patients access to Rasonque after prior systemic therapy or if multiagent therapy is unsuitable. The Phase 3 trial results showed median overall survival of 13.2 months, compared with 6.7 months for chemotherapy.