MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in specific adult patients with metastatic pancreatic adenocarcinoma. The FDA announced this decision on August 26, 2026. This approval is applicable to individuals who have previously undergone at least one systemic therapy and includes those who are unable to receive multiagent systemic treatment. Revolution Medicines created this oral medication, targeting the RAS GTPase protein family. Patients are advised to take 300 milligrams of the drug once daily as the recommended dose.
The regulatory decision was based on findings from the Phase 3 RASolute 302 clinical trial, which involved 500 adults with metastatic pancreatic adenocarcinoma. These patients’ cancer had advanced after one prior systemic treatment. Researchers randomized 248 participants to receive daraxonrasib and 252 to physician-chosen chemotherapy. The median overall survival was 13.2 months for those treated with daraxonrasib, whereas patients on chemotherapy had a median survival of 6.7 months. The study reported a hazard ratio for death of 0.40, indicating a significant difference between the two groups.
In addition to improving overall survival, daraxonrasib demonstrated benefits in other critical measures. Median progression-free survival was 7.2 months in the daraxonrasib group, compared to 3.6 months in the chemotherapy cohort. The objective response rate reached 30% with daraxonrasib and 11% with chemotherapy. The study’s results showed statistically meaningful differences in overall survival, progression-free survival, and response rate. These key clinical findings underpin the FDA’s approval for previously treated metastatic pancreatic adenocarcinoma.
Clinical trial outcomes endorse targeted therapy approval
Daraxonrasib functions by inhibiting active RAS proteins that promote cancer progression. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify that patients must have a particular RAS mutation for this indication. Treatment with daraxonrasib continues until disease progression or intolerable side effects occur. Revolution Medicines developed Rasonque as an oral option tailored for this specific patient group, offering a targeted treatment alternative following initial systemic therapies.
Safety assessments during the Phase 3 trial revealed that 61.8% of patients on daraxonrasib experienced Grade 3 or higher adverse events. Among those receiving chemotherapy, the rate was 69.6%. Discontinuation due to treatment-related adverse events occurred in 1.2% of daraxonrasib patients, versus 11.2% in the chemotherapy group. Common side effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, loss of appetite, edema, mouth inflammation, and bleeding.
International cooperation influenced FDA review process
The prescribing information for Rasonque includes warnings for multiple serious risks, such as skin and soft tissue toxicity, oral disorders, severe diarrhea, and gastrointestinal perforation. Additional warnings cover interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA employed expedited review programs for this oncology application, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, and announced that the approval was finalized approximately 6.5 months ahead of the agency’s target date.
Furthermore, the FDA evaluated the application through Project Orbis, which fosters collaborative review efforts among international cancer regulatory agencies. Health Canada participated in the review process, along with official observers from European and Japanese regulators. In the United States, daraxonrasib received Breakthrough Therapy and Orphan Drug designations. The approval allows eligible U.S. patients to access Rasonque following prior systemic therapy or when multiagent treatment is unsuitable. The Phase 3 trial demonstrated a median overall survival of 13.2 months versus 6.7 months for chemotherapy.