MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, known chemically as daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. The FDA announced this approval on August 26, 2026. This authorization is applicable to individuals who have already undergone at least one systemic therapy and to those who are unable to receive multiagent systemic therapy. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family. Patients are advised to take a dose of 300 milligrams daily as recommended.
The approval was based on findings from the Phase 3 RASolute 302 trial, which included 500 adult participants with metastatic pancreatic adenocarcinoma. All participants had experienced disease progression following one prior systemic treatment. Researchers randomly assigned 248 patients to receive daraxonrasib, while 252 received physician-selected chemotherapy. The median overall survival was recorded at 13.2 months for those treated with daraxonrasib, compared to 6.7 months for the chemotherapy group. The trial’s hazard ratio for death was 0.40, indicating a significant difference between the two treatments.
Additional key efficacy endpoints also favored daraxonrasib. Median progression-free survival was 7.2 months in the daraxonrasib group versus 3.6 months in the chemotherapy cohort. The objective response rate stood at 30% for daraxonrasib, whereas it was 11% with chemotherapy. The study demonstrated statistically meaningful differences in overall survival, progression-free survival, and response rate, which formed the core clinical evidence supporting the FDA’s approval for patients with previously treated metastatic pancreatic adenocarcinoma.
Clinical trial findings underpin targeted therapy authorization
Daraxonrasib functions by inhibiting active forms of RAS proteins that can promote cancer proliferation. Mutations in RAS are identified in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify that patients must possess a particular RAS mutation to receive this therapy. Treatment persists until disease progression or intolerable side effects emerge. Revolution Medicines introduced Rasonque as an oral treatment option for this defined group, providing a targeted approach following initial systemic therapies.
The Phase 3 trial also examined safety outcomes related to the treatment. Grade 3 or higher adverse events occurred in 61.8% of patients treated with daraxonrasib, compared to 69.6% in the chemotherapy group. Treatment-related adverse events caused 1.2% of daraxonrasib patients to discontinue therapy, versus 11.2% in the chemotherapy cohort. Common side effects included rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, reduced appetite, edema, mouth inflammation, and bleeding.
Regulatory review involved international cooperation
The prescribing information for Rasonque includes warnings for several serious risks such as skin and soft tissue toxicity, oral disorders, severe diarrhea, and gastrointestinal perforation. It also warns about interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA utilized expedited review programs for oncology drugs when evaluating the submission, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated that it completed the approval approximately 6.5 months ahead of its regulatory target date.
Furthermore, the FDA assessed the application through Project Orbis, an initiative promoting coordinated review among international cancer regulatory agencies. Health Canada collaborated on the review process. Regulatory agencies from Europe and Japan also participated as official observers. In addition, daraxonrasib has been granted Breakthrough Therapy and Orphan Drug designations within the United States. This approval grants eligible U.S. patients access to Rasonque after prior systemic therapy or when multiagent regimens are unsuitable. The Phase 3 trial results revealed a median overall survival of 13.2 months, significantly longer than the 6.7 months observed with chemotherapy.
}}}}#xusqkya9tt