MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in specific adult patients with metastatic pancreatic adenocarcinoma. This once-daily tablet received clearance from the FDA on August 26, 2026, offering a new targeted option for patients. The approval extends to adults who have undergone at least one prior systemic treatment, including those who are ineligible for multiagent systemic therapy. 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, randomized, open-label, multicenter trial involving 500 adult participants. These patients had metastatic pancreatic adenocarcinoma that advanced after one previous line of systemic therapy. Researchers assigned 248 patients to receive daraxonrasib, while 252 received physician-chosen standard chemotherapy. Results showed a median overall survival of 13.2 months with daraxonrasib compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
In addition, progression-free survival also saw improvements in the full trial population. Patients on daraxonrasib experienced a median progression-free survival of 7.2 months, versus 3.6 months for those on standard chemotherapy. The objective response rate was 30% in the daraxonrasib group, compared to 11% in the chemotherapy cohort. These differences in overall survival, progression-free survival, and response rate were statistically meaningful. The data support the drug’s use in patients whose metastatic disease has already necessitated systemic therapy.
Targeted therapy interferes with RAS signaling pathway
Daraxonrasib functions as an inhibitor of RAS, crafted to obstruct 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, with a recommended dose of 300 milligrams once daily. Treatment continues until disease progression or unacceptable toxicity occurs. The approval pertains to metastatic pancreatic adenocarcinoma and does not require the presence of a specific RAS mutation for prescribing.
Safety data indicated that adverse events occurred across all patients treated with daraxonrasib in the Phase 3 trial. Grade 3 or higher adverse events affected 61.8% of the daraxonrasib group and 69.6% of those on chemotherapy. Treatment-related adverse events resulted in discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects reported include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, reduced appetite, and bleeding. The prescribing information also lists several serious warnings and precautions.
Regulatory review expedited via priority review programs
These warnings encompass 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 evaluated the application through multiple accelerated oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced approval approximately 6.5 months ahead of its targeted timeline. Daraxonrasib additionally received Breakthrough Therapy and Orphan Drug designations.
The FDA employed Project Orbis for the review process, facilitating collaboration with other national regulators on oncology submissions. Health Canada participated in the review, with European and Japanese regulators acting as official observers. The FDA indicated that applications might still be under review in other agencies. This approval grants Revolution Medicines the authorization to market Rasonque for this specific U.S. patient group. For patients with previously treated metastatic pancreatic adenocarcinoma, the key Phase 3 trial reported a median overall survival of 13.2 months versus 6.7 months with chemotherapy.