MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, for specific adult patients diagnosed with metastatic pancreatic adenocarcinoma. This decision was publicly announced on August 26, 2026. The authorization is applicable to patients who have previously undergone at least one systemic treatment and includes those who are unable to receive multiagent systemic therapy. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family. The recommended dosage is 300 milligrams once daily for patients.
The approval was based on outcomes from the Phase 3 RASolute 302 trial, involving 500 adults with metastatic pancreatic adenocarcinoma whose disease advanced after a prior systemic therapy. Researchers randomized 248 patients to receive daraxonrasib and 252 to physician-chosen chemotherapy. The median overall survival with daraxonrasib was 13.2 months, whereas patients on chemotherapy had a median survival of 6.7 months. The trial demonstrated a hazard ratio for death of 0.40, indicating a significant difference favoring the treatment group.
In addition to overall survival, daraxonrasib showed improvements in other critical endpoints. The median progression-free survival was 7.2 months for the daraxonrasib group, compared to 3.6 months for those on chemotherapy. The objective response rate was 30% with daraxonrasib versus 11% with chemotherapy. Statistically significant differences were observed across overall survival, progression-free survival, and response rate, forming the core clinical evidence supporting the FDA’s approval for patients with previously treated metastatic pancreatic adenocarcinoma.
Clinical trial outcomes underpin targeted therapy authorization
Daraxonrasib functions by inhibiting the active forms of RAS proteins responsible for driving cancer progression. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not require patients to harbor a specific RAS mutation for this indication. Treatment continues until cancer progression or intolerable side effects occur. Revolution Medicines developed Rasonque as an oral option for this patient population, offering a targeted therapy following earlier systemic treatments.
The Phase 3 trial also assessed safety outcomes related to treatment. Grade 3 or higher adverse events occurred in 61.8% of daraxonrasib recipients, compared to 69.6% among those receiving chemotherapy. Treatment-related adverse events resulted in therapy discontinuation for 1.2% of patients on daraxonrasib, versus 11.2% in the chemotherapy arm. Common side effects reported include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
International regulatory collaboration facilitated FDA review
The prescribing information for Rasonque includes warnings for several serious risks, such as skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. During evaluation, the FDA utilized expedited oncology review programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency indicated that it finalized the approval approximately 6.5 months prior to the target date.
The FDA’s review process was part of Project Orbis, which promotes coordinated evaluation among international cancer regulators. Health Canada participated in the review as a collaborator. European and Japanese authorities also observed the process. Daraxonrasib has been granted Breakthrough Therapy and Orphan Drug designations in the United States. This approval grants eligible U.S. patients access to Rasonque following previous systemic therapy or when multiagent therapy is unsuitable, with clinical trial data showing median overall survival of 13.2 months versus 6.7 months with chemotherapy.