MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, also known as daraxonrasib, for use in specific adult patients with metastatic pancreatic adenocarcinoma. This once-daily oral tablet received clearance on August 26, 2026, providing a new targeted treatment option for patients. The approval includes adults who have undergone at least one prior systemic therapy and those ineligible for multiagent systemic treatments. Revolution Medicines is the manufacturer behind this drug, which specifically targets the RAS GTPase family.
This authorization was based on data from RASolute 302, a Phase 3, multicenter, randomized, open-label trial involving 500 adults. All participants had metastatic pancreatic adenocarcinoma that progressed following one prior systemic treatment. Researchers randomized 248 patients to receive daraxonrasib and 252 to a physician-selected standard chemotherapy. Results showed a median overall survival of 13.2 months for those on daraxonrasib, compared to 6.7 months for the chemotherapy group. The FDA reported a hazard ratio for death of 0.40.
In addition, progression-free survival was notably better among the full trial population. Patients treated with daraxonrasib experienced a median progression-free survival of 7.2 months, whereas 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, supporting the drug’s use for patients with metastatic disease who have already undergone systemic therapy.
Targeted Therapy Focuses on RAS Pathway
Daraxonrasib functions as a RAS inhibitor, designed to obstruct active forms of RAS proteins that promote tumor growth. Given that RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas, the drug is administered orally at a dose of 300 milligrams once daily. Treatment continues until the disease progresses or unacceptable toxicity occurs. The approval covers metastatic pancreatic adenocarcinoma, regardless of specific RAS mutation status in the patient.
Safety data indicated that adverse events impacted all patients receiving daraxonrasib in the Phase 3 trial. Grade 3 or higher adverse events affected 61.8% of the daraxonrasib group and 69.6% of those on chemotherapy. Discontinuation due to treatment-related adverse events occurred in 1.2% and 11.2%, respectively. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also includes several serious warnings and precautions.
Accelerated FDA Review Process for Oncology Drugs
Warnings associated with the drug involve skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also cautions against embryo-fetal toxicity. The FDA expedited the review through programs such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that it approved the application approximately 6.5 months before the target date. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
The FDA employed Project Orbis for this review, facilitating collaboration with other national regulators on oncology submissions. Health Canada contributed to the review process, with European and Japanese regulators participating as official observers. The FDA noted that applications might still be under review elsewhere. This approval grants Revolution Medicines the Rasonque authorization for the specified U.S. patient group. Notably, the key Phase 3 trial revealed a median overall survival of 13.2 months with daraxonrasib versus 6.7 months with chemotherapy for previously treated metastatic pancreatic adenocarcinoma.