MARYLAND / RankWire.AI / – U.S. Food and Drug Administration has authorized Rasonque, also known as daraxonrasib, for specific adult individuals diagnosed with metastatic pancreatic adenocarcinoma. The agency approved the once-daily pill on August 26, 2026, providing a new, precision-based treatment option for affected patients. This approval applies to adults who have previously undergone at least one systemic therapy, as well as those who are unsuitable for multiagent systemic treatments. The drug was developed by Revolution Medicines and specifically targets the RAS GTPase family.
The approval was based on findings from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that advanced after one prior systemic treatment. 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 reported a hazard ratio for death of 0.40.
Progression-free survival also showed improvement across the entire study population. Patients treated with daraxonrasib experienced a median progression-free survival of 7.2 months, whereas those on standard chemotherapy had 3.6 months. 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 were statistically significant. The data support the drug’s use in patients whose metastatic disease has already required systemic therapy.
Targeted medication impacts RAS signaling pathway
Daraxonrasib functions as a RAS inhibitor designed to block active forms of RAS proteins responsible for tumor growth. RAS mutations are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a recommended dose of 300 milligrams once daily. Treatment continues until disease progression or unacceptable toxicity occurs. The approval is for metastatic pancreatic adenocarcinoma and does not necessitate a specific RAS mutation for prescribing.
Safety analysis revealed that adverse events occurred in all patients who received daraxonrasib during the Phase 3 trial. Grade 3 or higher adverse events affected 61.8% of those treated with daraxonrasib and 69.6% of those receiving chemotherapy. Treatment-related adverse events caused discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, loss of appetite, and bleeding. The prescribing information also emphasizes several serious warnings and precautions.
Expedited review process facilitated FDA approval
These warnings include skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. The label also includes a warning for embryo-fetal toxicity. The FDA evaluated the application through multiple accelerated oncology programs, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency indicated it approved the application approximately 6.5 months ahead of its target date. Daraxonrasib also received Breakthrough Therapy and Orphan Drug designations.
The FDA employed Project Orbis for this review, enabling collaboration with other regulatory agencies on oncology applications. Health Canada participated in the review process, along with official observers from Europe and Japan. The FDA noted that other agencies may still be reviewing the application. This approval grants Revolution Medicines the authorization for Rasonque in the U.S. for this specific patient population. The key Phase 3 outcome for previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months versus 6.7 months with chemotherapy, respectively.