MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. The agency authorized the once-per-day tablet on August 26, 2026, providing a targeted therapy alternative for patients. This approval applies to adults who have previously undergone at least one systemic therapy and also to those who are unsuitable candidates for multiagent systemic treatment. The medication was developed by Revolution Medicines, targeting the RAS GTPase family.
This approval was based on findings from RASolute 302, an open-label, randomized Phase 3 trial conducted across multiple centers involving 500 adult participants. These individuals had metastatic pancreatic adenocarcinoma that had progressed after one prior systemic treatment. Researchers allocated 248 patients to receive daraxonrasib and 252 to standard chemotherapy selected by their physicians. The median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
In addition to overall survival, progression-free survival showed notable improvement across the entire study cohort. Median progression-free survival was 7.2 months for those on daraxonrasib, compared to 3.6 months for those on standard chemotherapy. 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, supporting the drug’s use in patients with metastatic disease who have already undergone systemic treatment.
Targeted therapy impacts RAS pathway
Daraxonrasib is an inhibitor designed to interfere with RAS proteins, which promote tumor growth when active. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a dosage of 300 milligrams once daily, with treatment continuing until disease progression or intolerable side effects occur. The FDA’s approval covers metastatic pancreatic adenocarcinoma and does not specify the presence of a RAS mutation as a criterion for prescribing.
Safety analysis from the Phase 3 trial revealed that all patients treated with daraxonrasib experienced adverse events. Grade 3 or higher adverse effects were observed in 61.8% of patients on daraxonrasib and 69.6% on chemotherapy. Treatment discontinuation due to adverse events occurred in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy group. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, loss of appetite, and bleeding. The prescribing information also emphasizes several serious warnings and precautions.
Fast-tracked review process by the FDA
Key safety warnings include skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Embryo-fetal toxicity is also highlighted. The FDA expedited its review through multiple oncology-specific programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that approval was granted approximately 6.5 months ahead of its scheduled target date. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
The review process incorporated Project Orbis, which facilitates cooperation with other national regulators on oncology submissions. Health Canada participated in the review, with European and Japanese regulators serving as official observers. The FDA indicated that applications could still be under review by other agencies. This approval marks the first regulatory authorization of Rasonque for Revolution Medicines in the U.S. for this specific patient group. The pivotal Phase 3 trial demonstrated a median overall survival of 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.