MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, or daraxonrasib, for certain adults diagnosed with metastatic pancreatic adenocarcinoma. The FDA authorized the once-daily tablet on August 26, 2026, providing patients with a new targeted therapy option. This approval extends to adults who have undergone at least one prior systemic treatment and also includes those who are ineligible for multiagent systemic therapies. Revolution Medicines developed this medication, which specifically targets the RAS GTPase family.
Following the results of RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults, the FDA’s decision was made. Participants had metastatic pancreatic adenocarcinoma that continued to worsen after one systemic therapy. Researchers allocated 248 patients to receive daraxonrasib, while 252 received physician-chosen standard chemotherapy. The median overall survival was 13.2 months for those on daraxonrasib compared to 6.7 months for the chemotherapy group, with a hazard ratio for death of 0.40 reported by the FDA.
In addition, the trial showed an increase in progression-free survival, with median times of 7.2 months versus 3.6 months for daraxonrasib and standard chemotherapy, respectively. The objective response rate was 30% in the daraxonrasib cohort and 11% among those receiving chemotherapy. The statistically significant differences in overall survival, progression-free survival, and response rate endorse the drug’s use in patients with metastatic disease who have already undergone systemic treatment.
Targeted Therapy Interferes with RAS Pathway
Daraxonrasib functions as a RAS inhibitor aimed at blocking the active forms of RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a standard dose of 300 milligrams once daily and is continued until disease progression or intolerable toxicity occurs. The approval encompasses metastatic pancreatic adenocarcinoma regardless of RAS mutation status in the prescribing indication.
Safety data from the Phase 3 trial revealed that adverse events affected all patients treated with daraxonrasib. Grade 3 or higher adverse events were observed in 61.8% of the daraxonrasib group and 69.6% of those on chemotherapy. Treatment discontinuation due to adverse events happened in 1.2% of the daraxonrasib group and 11.2% of the chemotherapy group. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also highlights several serious warnings and precautions.
Accelerated Review Pathways Facilitated Approval
The label includes warnings related to skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. It also cautions about embryo-fetal toxicity. The application was reviewed under several expedited oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The FDA stated that it approved the application approximately 6.5 months ahead of its target date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The review process involved Project Orbis, allowing collaboration with other national regulators on oncology submissions. Health Canada participated in the review, along with official observers from European and Japanese agencies. The FDA indicated that other agencies might still be reviewing the application. This approval grants Revolution Medicines the Rasonque authorization for this specific U.S. patient group. The key Phase 3 trial result for patients with previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months versus 6.7 months with chemotherapy.