MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, also known as daraxonrasib, for specific adult patients suffering from metastatic pancreatic adenocarcinoma. The agency announced this approval on August 26, 2026. This authorization applies to individuals who have undergone at least one prior systemic therapy and includes those unable to receive multiagent systemic regimens. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family. Patients are advised to take a dose of 300 milligrams once daily as recommended.
The decision was supported by results from the Phase 3 RASolute 302 trial, which included 500 adults with metastatic pancreatic adenocarcinoma. All participants’ cancers had advanced following one previous systemic treatment. Researchers randomized 248 patients to receive daraxonrasib and 252 to the physician’s choice of chemotherapy. The median overall survival was 13.2 months for those on daraxonrasib, compared to 6.7 months for the chemotherapy group. The study reported a hazard ratio for death of 0.40, indicating a significant difference between the two treatment arms.
In addition to overall survival, daraxonrasib demonstrated improvements in other critical endpoints. The median progression-free survival reached 7.2 months with daraxonrasib, while the chemotherapy group experienced 3.6 months. The objective response rate was 30% for daraxonrasib versus 11% with chemotherapy. The clinical data showed statistically meaningful differences across overall survival, progression-free survival, and response rate, forming the core evidence supporting FDA approval for this patient group with previously treated metastatic pancreatic cancer.
Clinical trial findings underpin targeted therapy authorization
Daraxonrasib acts by blocking active RAS proteins, which can promote tumor growth. Mutations in RAS are present in more than 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify that patients need to have a particular RAS mutation to qualify for this treatment. Therapy continues until disease progression or intolerable side effects occur. Revolution Medicines designed Rasonque as an oral option for this defined patient population, providing a targeted approach following earlier systemic treatments.
Safety assessments in the Phase 3 trial revealed that 61.8% of patients treated with daraxonrasib experienced grade 3 or higher adverse events. For those receiving chemotherapy, the rate was 69.6%. Treatment-related adverse events prompted 1.2% of daraxonrasib patients to discontinue therapy, whereas 11.2% of chemotherapy patients stopped due to side effects. Common adverse reactions include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
International collaboration influenced FDA review process
The prescribing information for Rasonque contains warnings for several severe risks, including skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA employed expedited oncology review programs for this submission, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated it finalized approval approximately 6.5 months ahead of its regulatory target date.
Additionally, the FDA evaluated the application through Health Canada as part of Project Orbis, which facilitates coordinated reviews among international cancer regulators. European and Japanese authorities participated as official observers. Moreover, daraxonrasib received Breakthrough Therapy and Orphan Drug designations within the United States. This approval enables eligible U.S. patients to access Rasonque following prior systemic therapy or when multiagent regimens are unsuitable. The Phase 3 trial reported a median overall survival of 13.2 months, compared with 6.7 months for chemotherapy.