MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has authorized Rasonque, or daraxonrasib, as a treatment option for certain adults with metastatic pancreatic adenocarcinoma. The FDA approved the once-daily tablet on August 26, 2026, providing patients with a novel targeted therapy. This approval is intended for adults who have undergone at least one prior systemic therapy and for those ineligible for multiagent systemic treatment. The drug was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The decision was based on results from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults with metastatic pancreatic adenocarcinoma that had progressed after one line of systemic therapy. Researchers assigned 248 patients to receive daraxonrasib and 252 to standard chemotherapy selected by their physicians. The median overall survival was 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy. The FDA noted a hazard ratio for death of 0.40.
Progression-free survival also saw notable improvements across the entire trial population. Patients treated with 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% for the daraxonrasib group and 11% for the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically significant. The findings support the use of the drug in patients whose metastatic disease has already required systemic therapy.
Targeted therapy inhibits RAS pathway activity
Daraxonrasib functions as a RAS inhibitor designed to block active forms of RAS proteins, which are involved in promoting tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a recommended dose of 300 milligrams once daily, with treatment continuing until disease progression or unacceptable toxicity occurs. The approval covers metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation for prescribing.
Safety data indicated that adverse events happened in all patients who received daraxonrasib in the Phase 3 trial. Grade 3 or higher adverse events were reported in 61.8% of the daraxonrasib group and 69.6% of the chemotherapy group. Treatment-related adverse events led to discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, reduced appetite, and bleeding. The prescribing information also details several serious warnings and precautions.
Expedited review process facilitated by priority programs
These warnings encompass skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also alerts to embryo-fetal toxicity. The FDA’s review process utilized multiple fast-track oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that it approved the application approximately 6.5 months ahead of its target date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
Additionally, the FDA employed Project Orbis, which enables collaboration with other national regulators on oncology submissions. Health Canada participated in the review, along with official observers from European and Japanese regulators. The FDA noted that other agencies may still be reviewing the application. This approval grants Revolution Medicines the authorization to market Rasonque for this specific U.S. patient group. The key Phase 3 trial result for previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months compared to 6.7 months with chemotherapy, underscoring the treatment’s potential benefit.