MARYLAND / RankWire.AI / – U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. The FDA announced this decision on August 26, 2026. The approval applies to individuals who have undergone at least one prior systemic therapy. It also includes adults who are unable to receive multiagent systemic treatments. The oral medication was developed by Revolution Medicines and specifically targets the RAS GTPase protein family. Patients are advised to take a dose of 300 milligrams once daily, as recommended.
This approval was based on the results of the Phase 3 RASolute 302 clinical trial, which involved 500 adults diagnosed with metastatic pancreatic adenocarcinoma. All participants had experienced cancer progression following one previous line of systemic treatment. Researchers assigned 248 patients to receive daraxonrasib, while 252 were given chemotherapy chosen by their physicians. The median overall survival for the daraxonrasib group was 13.2 months, compared to 6.7 months among those on chemotherapy. The trial reported a hazard ratio for death of 0.40, indicating a significant difference between the two groups.
In addition to extending overall survival, daraxonrasib showed improvement in other key clinical endpoints. The median progression-free survival was 7.2 months with daraxonrasib, whereas the chemotherapy group had 3.6 months. The objective response rate was 30% with daraxonrasib, versus 11% with chemotherapy. The study identified statistically meaningful differences in overall survival, progression-free survival, and response rate. These findings constitute the primary clinical evidence supporting the FDA’s approval for previously treated metastatic pancreatic adenocarcinoma.
Clinical trial results underpin approval of targeted therapy
Daraxonrasib functions by blocking active forms of RAS proteins that can promote cancer growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The prescribing information does not specify a requirement for patients to have a particular RAS mutation for this treatment. Therapy continues until disease progression or intolerable side effects develop. Revolution Medicines designed Rasonque as an oral option for this specific patient population, providing a targeted therapy following earlier systemic treatments.
The Phase 3 trial also assessed safety outcomes related to the treatment. Grade 3 or higher adverse events were reported in 61.8% of patients treated with daraxonrasib. Among chemotherapy recipients, the rate was 69.6%. Treatment discontinuation due to adverse events occurred in 1.2% of daraxonrasib patients, compared to 11.2% in the chemotherapy group. Common adverse effects include rash, diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite, edema, mouth inflammation, and bleeding.
Global regulatory review involved international collaboration
The prescribing information for Rasonque includes warnings for several serious risks. These encompass skin and soft tissue toxicity, oral disorders, severe diarrhea, gastrointestinal perforation, interstitial lung disease or pneumonitis, and embryo-fetal toxicity. The FDA utilized expedited oncology review pathways during the application assessment. These included the Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency noted that it finalized the approval approximately 6.5 months ahead of its regulatory target date.
Additionally, the FDA evaluated the submission through Project Orbis, which promotes coordinated reviews among international cancer regulators. Health Canada participated in the review process. Regulators from Europe and Japan also observed as official partners. Daraxonrasib was awarded Breakthrough Therapy and Orphan Drug designations within the United States. This approval enables eligible U.S. patients to access Rasonque after previous systemic therapy or when multiagent approaches are unsuitable. The Phase 3 trial demonstrated a median overall survival of 13.2 months, significantly higher than the 6.7 months observed with chemotherapy.