MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for certain adult patients with metastatic pancreatic adenocarcinoma. The agency cleared this once-daily tablet on August 26, 2026, offering a targeted therapy choice for patients. The approval applies to adults who have already undergone at least one systemic treatment. It also includes those who are not suitable candidates for multiagent systemic therapy. The drug was developed by Revolution Medicines and targets the RAS GTPase family.
This decision was based on data from RASolute 302, a Phase 3 trial involving 500 adults. The trial was randomized, open-label, and multicenter. Participants had metastatic pancreatic adenocarcinoma that advanced after one prior systemic therapy. Researchers assigned 248 patients to receive daraxonrasib, while 252 received standard chemotherapy chosen by their doctors. The median overall survival was 13.2 months for those on daraxonrasib, compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Progression-free survival also saw improvement across the full study population. Patients on daraxonrasib had a median progression-free survival of 7.2 months, while those on standard chemotherapy had 3.6 months. The objective response rate was 30% for the daraxonrasib group and 11% for the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically significant. The findings support the use of daraxonrasib in patients with metastatic disease requiring systemic treatment.
Targeted medication works on RAS pathway
Daraxonrasib is a RAS inhibitor designed to block active forms of RAS proteins that promote tumor growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. Patients take 300 milligrams of the drug orally once a day. Treatment continues until the disease progresses or toxicity becomes unacceptable. The approval covers metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation for prescribing.
Safety data showed adverse events in all patients treated with daraxonrasib during the Phase 3 trial. Grade 3 or higher adverse events affected 61.8% of patients in the daraxonrasib group and 69.6% in the chemotherapy group. Treatment-related adverse events led to discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, reduced appetite, and bleeding. The prescribing information lists several serious warnings and precautions.
FDA review advanced through priority pathways
Warnings include skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also cautions about embryo-fetal toxicity. The FDA evaluated the application through several expedited oncology programs, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency said it approved the application roughly 6.5 months before its target date. Daraxonrasib also earned Breakthrough Therapy and Orphan Drug designations.
The FDA utilized Project Orbis for the review, facilitating cooperation with other national regulators on oncology drugs. Health Canada participated in the review, along with official observers from European and Japanese regulators. The FDA indicated that the application may still be under review elsewhere. This approval grants Revolution Medicines its Rasonque authorization for this specific 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.