MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has approved Rasonque, or daraxonrasib, for certain adults with metastatic pancreatic adenocarcinoma. The FDA cleared the once-daily tablet on August 26, 2026, giving patients a new targeted treatment option. The approval covers adults who received at least one prior systemic therapy. It also covers patients who are not candidates for multiagent systemic therapy. Revolution Medicines developed the drug, which targets the RAS GTPase family.
The approval followed results from RASolute 302, a randomized, open-label, multicenter Phase 3 trial involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that progressed after one previous line of systemic therapy. Researchers assigned 248 patients to daraxonrasib and 252 to standard chemotherapy chosen by physicians. Median overall survival reached 13.2 months with daraxonrasib, compared with 6.7 months for chemotherapy. The FDA reported a hazard ratio for death of 0.40.
Progression-free survival also improved in the full trial population. 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 and 11% in the chemotherapy group. The differences in overall survival, progression-free survival and response rate were statistically significant. The results support the drug’s use in patients whose metastatic disease has already required systemic treatment.
Targeted drug acts on RAS pathway
Daraxonrasib is a RAS inhibitor designed to block active forms of RAS proteins that drive tumor growth. RAS mutations appear in more than 90% of pancreatic ductal adenocarcinomas. The drug is taken orally at a recommended dose of 300 milligrams once daily. Treatment continues until disease progression or unacceptable toxicity. The approval applies to metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation in the prescribing indication.
Safety data showed that adverse events occurred in all patients who received daraxonrasib in the Phase 3 trial. Grade 3 or higher adverse events affected 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 lists several serious warnings and precautions.
FDA review moved through priority programs
Those warnings include skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation and interstitial lung disease or pneumonitis. The label also warns of embryo-fetal toxicity. The FDA reviewed the application through several expedited oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency said it approved the application about 6.5 months before its goal date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The FDA used Project Orbis for the review, allowing collaboration with other national regulators on oncology applications. Health Canada collaborated in the review, while European and Japanese regulators participated as official observers. The FDA said applications may still be under review at other agencies. The approval gives Revolution Medicines its Rasonque authorization for this defined U.S. patient population. For 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.