MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for select adult patients with metastatic pancreatic adenocarcinoma. The agency authorized the once-daily tablet on August 26, 2026, offering a new targeted therapy option for patients. This approval extends to adults who have previously undergone at least one systemic treatment and to those ineligible for multiagent systemic therapy. The medication was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The decision was based on outcomes from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that had advanced following one prior systemic therapy. Researchers allocated 248 patients to receive daraxonrasib and 252 to standard chemotherapy selected 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 FDA reported a hazard ratio for death of 0.40.
In addition, progression-free survival saw notable gains. The median progression-free survival was 7.2 months with daraxonrasib and 3.6 months with standard chemotherapy. The objective response rate was 30% in the daraxonrasib group versus 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate reached statistical significance. The findings support using the drug in patients with metastatic disease that has already been treated systemically.
Targeted medication inhibits RAS pathway
Daraxonrasib functions as a RAS inhibitor aimed at blocking active RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. Patients take the drug orally at a recommended dose of 300 milligrams daily. Treatment continues until disease progression or intolerable side effects occur. This approval pertains to metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation for prescribing.
Safety results indicated that adverse events affected all participants receiving daraxonrasib during the Phase 3 trial. Grade 3 or higher adverse events impacted 61.8% of patients in the daraxonrasib group and 69.6% in the chemotherapy group. Treatment-related adverse events led to discontinuation 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.
Fast-tracked review through priority programs
Among the warnings are skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also cautions about embryo-fetal toxicity. The FDA expedited the review process via several oncology-focused programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced it approved the application approximately 6.5 months before its target date. Daraxonrasib also earned Breakthrough Therapy and Orphan Drug designations.
The review utilized Project Orbis, facilitating collaboration with other national regulators on oncology drug approvals. Health Canada participated in the review, alongside official observers from European and Japanese regulators. The FDA indicated that applications may still be under review by other agencies. This approval grants Revolution Medicines the Rasonque license for this specific U.S. patient group. In patients with previously treated metastatic pancreatic adenocarcinoma, the key Phase 3 result was a median overall survival of 13.2 months versus 6.7 months with chemotherapy.