MARYLAND / RankWire.AI / – On August 26, 2026, the U.S. Food and Drug Administration granted approval to Rasonque, also known as daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. This approval encompasses individuals who have previously undergone at least one systemic therapy and those unable to receive multiagent systemic treatment. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family, with patients advised to take a dose of 300 milligrams daily.
The decision was based on results from the Phase 3 RASolute 302 study, which included 500 adults with metastatic pancreatic adenocarcinoma whose disease progressed following one prior systemic treatment. Researchers randomized 248 patients to receive daraxonrasib and 252 to physician-selected chemotherapy. The median overall survival for those treated with daraxonrasib was 13.2 months, whereas patients on chemotherapy had a median survival of 6.7 months. The trial reported a hazard ratio for death of 0.40, indicating a significant difference favoring daraxonrasib.
In addition to overall survival, the trial demonstrated improvements in other key measures. The median progression-free survival was 7.2 months with daraxonrasib compared to 3.6 months with chemotherapy. The objective response rate reached 30% for daraxonrasib, versus 11% with chemotherapy. Statistically significant differences were observed across overall survival, progression-free survival, and response rate, providing critical clinical evidence supporting the FDA’s approval for patients with previously treated metastatic pancreatic adenocarcinoma.
Clinical trial findings validate approval of targeted therapy
Daraxonrasib functions by inhibiting active forms of RAS proteins that contribute to cancer cell growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information, however, does not specify that patients must have a particular RAS mutation to receive this treatment. The drug is administered until disease progression or unacceptable side effects occur. Revolution Medicines developed Rasonque as an oral therapy aimed at this specific patient population, offering a targeted option following initial 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. Among those receiving chemotherapy, the rate was 69.6%. Treatment-related adverse events led 1.2% of daraxonrasib patients to discontinue therapy, compared to 11.2% in the chemotherapy group. Common side effects included rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mucosal inflammation, and bleeding.
International regulatory collaboration influenced FDA review process
The prescribing information for Rasonque includes warnings about serious risks such as skin and soft tissue toxicity, oral disorders, severe diarrhea, and gastrointestinal perforation. Additional concerns listed are interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA employed expedited oncology review pathways—specifically Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot—to evaluate the application. The agency announced that approval was granted approximately 6.5 months ahead of its regulatory target date.
Moreover, the FDA conducted a review through Health Canada as part of Project Orbis, which facilitates coordinated review among international cancer regulators. European and Japanese agencies participated as official observers. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations within the United States. The approval allows eligible U.S. patients access to Rasonque following prior systemic therapy or when multiagent therapy is not suitable. The Phase 3 trial demonstrated a median overall survival of 13.2 months, substantially longer than the 6.7 months observed with chemotherapy.
}the