MARYLAND / RankWire.AI / – U.S. Food and Drug Administration has approved Rasonque, or daraxonrasib, for specific adults battling metastatic pancreatic adenocarcinoma. The agency announced this decision on August 26, 2026. This approval applies to patients who have previously undergone at least one systemic therapy. It also covers adults who are ineligible for multiagent systemic treatment. Developed by Revolution Medicines, this oral medication targets the RAS GTPase family. Patients are advised to take 300 milligrams once daily as a recommended dose.
Approval was based on data from the Phase 3 RASolute 302 trial, which enrolled 500 adults with metastatic pancreatic adenocarcinoma. All participants’ cancer had advanced after one prior systemic therapy. Researchers randomly assigned 248 patients to receive daraxonrasib and 252 to physician-selected chemotherapy. The median overall survival was 13.2 months with daraxonrasib. Patients in the chemotherapy group had a median survival of 6.7 months. The trial showed a hazard ratio for death of 0.40, indicating a significant difference between the two groups.
The study also demonstrated improvements in other key outcomes. Median progression-free survival reached 7.2 months with daraxonrasib, compared to 3.6 months with chemotherapy. The objective response rate was 30% in the daraxonrasib group and 11% in the chemotherapy group. The data revealed statistically meaningful differences in overall survival, progression-free survival, and response rate. These findings served as the primary clinical evidence supporting the FDA’s approval for previously treated metastatic pancreatic adenocarcinoma.
Clinical trial results underpin targeted therapy approval
Daraxonrasib inhibits active forms of RAS proteins that can promote cancer growth. RAS mutations are present in more than 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify that patients need a particular RAS mutation to qualify for this treatment. Therapy continues until disease progression or intolerable side effects occur. Revolution Medicines developed Rasonque as an oral option for this specific patient group, offering a targeted approach after initial systemic treatments.
The Phase 3 trial also assessed safety. Grade 3 or higher adverse events occurred in 61.8% of patients on daraxonrasib. In the chemotherapy group, the rate was 69.6%. Treatment-related adverse events caused 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, reduced appetite, edema, mouth inflammation, and bleeding.
International regulatory cooperation contributed to FDA review
The prescribing information for Rasonque includes warnings for serious risks. These involve skin and soft tissue toxicity, oral disorders, severe diarrhea, and gastrointestinal perforation. It also warns of interstitial lung disease or pneumonitis and embryo-fetal toxicity. The FDA utilized expedited oncology review programs during the evaluation. These included Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated it approved the drug about 6.5 months before its regulatory target date.
Additionally, the FDA reviewed the application through Project Orbis, fostering coordinated efforts among international cancer regulators. Health Canada participated in the review process. European and Japanese regulators observed as official partners. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations in the United States. The approval enables eligible U.S. patients to access Rasonque after prior systemic therapy or if multiagent therapy is unsuitable. Its Phase 3 trial showed a median overall survival of 13.2 months, compared to 6.7 months with chemotherapy.
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