MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for specific adult individuals diagnosed with metastatic pancreatic adenocarcinoma. On August 26, 2026, the FDA authorized the use of this once-daily oral tablet, providing a new targeted option for patients. The approval applies to adults who have previously undergone at least one systemic therapy and also extends to those who are ineligible for multiagent systemic treatments. The drug was developed by Revolution Medicines and specifically targets the RAS GTPase family.
This approval was based on outcomes from RASolute 302, a Phase 3 trial that was randomized, open-label, and conducted across multiple centers, involving 500 adult participants. These patients had metastatic pancreatic adenocarcinoma that had advanced following a prior systemic therapy. Researchers allocated 248 patients to receive daraxonrasib, while 252 received standard chemotherapy selected by their doctors. The median overall survival was 13.2 months with daraxonrasib, compared to 6.7 months with chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Further, progression-free survival also showed notable improvement across the entire trial cohort. 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 stood at 30% for the daraxonrasib group, against 11% for the chemotherapy group. The differences observed in overall survival, progression-free survival, and response rate were statistically meaningful. These findings endorse the drug’s use in patients whose metastatic disease has necessitated systemic treatment.
Targeted medication inhibits RAS pathway activity
Daraxonrasib functions as an inhibitor of RAS, designed to obstruct active RAS proteins that promote tumor proliferation. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a recommended dose of 300 milligrams daily, with treatment continuing until the disease progresses or unacceptable side effects occur. The FDA’s approval encompasses metastatic pancreatic adenocarcinoma without requiring a specific RAS mutation in the prescribing criteria.
Adverse event data from the Phase 3 trial indicated that all patients receiving daraxonrasib experienced side effects. Grade 3 or higher adverse events affected 61.8% of those in the daraxonrasib group and 69.6% in the chemotherapy group. Treatment discontinuation due to adverse events occurred in 1.2% of patients on daraxonrasib and 11.2% on chemotherapy. Common side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, loss of appetite, and bleeding. The prescribing information also details several serious warnings and precautions.
Accelerated review process facilitated by priority programs
Among the warnings are risks related to skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label additionally cautions about embryo-fetal toxicity. The FDA expedited the review using various 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 the targeted date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The review process involved Project Orbis, which enables cooperation with other national regulators on oncology submissions. Health Canada participated in the review, with European and Japanese authorities acting as official observers. The FDA mentioned that applications might still be under assessment by other agencies. This approval grants Revolution Medicines the authorization for Rasonque for this specific U.S. patient group. The key Phase 3 trial demonstrated a median overall survival of 13.2 months, compared to 6.7 months with chemotherapy, in patients with previously treated metastatic pancreatic adenocarcinoma.