MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, for use in certain adults diagnosed with metastatic pancreatic adenocarcinoma. The FDA made this announcement on August 26, 2026. The authorization applies to patients who have previously undergone at least one systemic therapy and also includes adults who are ineligible for multiagent systemic treatments. Revolution Medicines developed this oral medication, which specifically targets the RAS GTPase family. Patients are advised to take the medication at a dose of 300 milligrams once daily, as recommended.
The decision was based on findings from the Phase 3 RASolute 302 trial, which involved 500 adults with metastatic pancreatic adenocarcinoma that had advanced after one prior systemic treatment. Researchers randomly assigned 248 patients to receive daraxonrasib, while 252 were given chemotherapy chosen by their physicians. The median overall survival for those treated with daraxonrasib was 13.2 months, compared to 6.7 months for the chemotherapy group. The trial demonstrated a hazard ratio for death of 0.40, indicating a significant difference between the two treatments.
Additional key outcomes favored daraxonrasib, including a median progression-free survival of 7.2 months versus 3.6 months with chemotherapy. The objective response rate was 30% for daraxonrasib, with only 11% in the chemotherapy cohort. Statistically significant differences were observed across overall survival, progression-free survival, and response rates, providing the core clinical evidence supporting the FDA’s approval for previously treated metastatic pancreatic adenocarcinoma.
Clinical trial results endorse targeted therapy approval
Daraxonrasib functions by inhibiting the active forms of RAS proteins, which can promote cancer growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. However, the prescribing information does not specify that patients must have a particular RAS mutation to receive this treatment. The medication is administered until disease progression or unacceptable side effects occur. Revolution Medicines introduced Rasonque as an oral option for this specific patient group, offering a targeted alternative following earlier systemic therapies.
Safety assessments in the Phase 3 trial indicated that 61.8% of patients treated with daraxonrasib experienced grade 3 or higher adverse events. Among those receiving chemotherapy, the rate was higher at 69.6%. Treatment-related adverse events led 1.2% of daraxonrasib patients to discontinue therapy, compared with 11.2% in the chemotherapy group. Common side effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
International regulatory cooperation played a role in 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. The FDA expedited the review process for this oncology product, utilizing programs like Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency noted that approval was finalized approximately 6.5 months ahead of its regulatory target date.
Moreover, the FDA evaluated the application through Project Orbis, an initiative designed to facilitate coordinated reviews among international cancer regulators. Health Canada collaborated in this review, with European and Japanese regulators participating as official observers. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations in the United States. This approval provides eligible U.S. patients with access to Rasonque after previous systemic therapy or when multiagent therapy is unsuitable, with the Phase 3 trial showing median overall survival of 13.2 months compared to 6.7 months with chemotherapy.