MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in specific adult cases of metastatic pancreatic adenocarcinoma. This once-daily tablet was authorized on August 26, 2026, providing a new targeted option for patients. The approval applies to adults who have previously undergone at least one systemic therapy and also to those unsuitable for multiagent systemic treatment. The drug was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The decision was based on data from RASolute 302, a Phase 3 trial that was randomized, open-label, and conducted across multiple centers involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that had progressed after one line of systemic therapy. Researchers assigned 248 patients to receive daraxonrasib and 252 to receive physician-chosen standard chemotherapy. The median overall survival with daraxonrasib was 13.2 months, compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Progression-free survival also showed improvement among the entire study group. Patients receiving daraxonrasib experienced a median progression-free survival of 7.2 months, versus 3.6 months for those on standard chemotherapy. The objective response rate stood at 30% in the daraxonrasib group, while it was 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically meaningful. The findings support the use of this drug in patients whose metastatic disease has already necessitated systemic therapy.
Targeted medication interacts with RAS signaling pathway
Daraxonrasib functions as a RAS inhibitor designed to suppress active forms of RAS proteins that contribute to tumor development. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The drug is administered orally at a recommended dose of 300 milligrams once daily. Patients continue treatment until disease progression or unacceptable toxicity occurs. The approval encompasses metastatic pancreatic adenocarcinoma without requiring a specific RAS mutation in the prescribing criteria.
Safety data indicated that adverse events impacted all patients who received daraxonrasib in the Phase 3 study. Grade 3 or higher adverse events occurred in 61.8% of those treated with daraxonrasib and 69.6% of patients on standard chemotherapy. Treatment discontinuation due to adverse events was reported 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, reduced appetite, and bleeding. The prescribing information also highlights several serious warnings and precautions.
Review process expedited through priority programs
These warnings cover skin and soft tissue toxicity, oral issues, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Additionally, the label warns about embryo-fetal toxicity. The FDA’s review of the application was expedited via several oncology-specific programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency stated it approved the application approximately 6.5 months ahead of its target date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The FDA utilized Project Orbis to facilitate collaboration with other national regulators on oncology submissions. Health Canada was involved in the review, with European and Japanese regulators participating as official observers. The FDA noted that applications might still be under review elsewhere. This approval grants Revolution Medicines the authorization to market Rasonque for this specific U.S. patient group. The key Phase 3 result for previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months compared to 6.7 months with chemotherapy.