MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for use in certain adult patients with metastatic pancreatic adenocarcinoma. On August 26, 2026, the FDA authorized the once-daily oral tablet, providing a new targeted therapy option for patients. This approval applies to adults who have previously undergone at least one systemic treatment and also to those who are unsuitable candidates 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 multicenter, randomized, open-label Phase 3 trial involving 500 adults. These participants had metastatic pancreatic adenocarcinoma that had progressed after one prior systemic therapy. Researchers assigned 248 patients to receive daraxonrasib, while 252 were treated with standard chemotherapy selected by their physicians. Results showed a median overall survival of 13.2 months for those on daraxonrasib, compared to 6.7 months for the chemotherapy group. The FDA reported a hazard ratio for death of 0.40.
Progression-free survival also demonstrated notable improvement across the trial population. The median progression-free survival was 7.2 months for the daraxonrasib group, versus 3.6 months for the standard treatment cohort. The objective response rate was 30% among patients treated with daraxonrasib and 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically meaningful. The findings support the use of the drug in patients with metastatic disease that has already been treated systemically.
Targeted therapy impacts RAS pathway
Daraxonrasib functions as a RAS inhibitor, designed to block active forms of RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. Patients typically take 300 milligrams of the medication orally once a day, with treatment continuing until disease progression or unacceptable toxicity occurs. The approval encompasses metastatic pancreatic adenocarcinoma regardless of RAS mutation status in the prescribed indication.
Safety data indicated that adverse events were experienced by all patients treated with daraxonrasib during the Phase 3 trial. Grade 3 or higher adverse events occurred in 61.8% of the daraxonrasib group and 69.6% of those receiving chemotherapy. Discontinuation due to treatment-related adverse events was reported in 1.2% of daraxonrasib patients and 11.2% of the chemotherapy group. Common side effects include rash, diarrhea, oral inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also details several serious warnings and precautions.
Expedited review process by the FDA
Warnings associated with the drug include skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. It also carries a warning for embryo-fetal toxicity. The FDA’s review was expedited through multiple oncology programs, such as Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency indicated that it approved the application approximately 6.5 months ahead of its target date. Daraxonrasib was granted Breakthrough Therapy and Orphan Drug designations.
Additionally, the FDA utilized Project Orbis, facilitating cooperation with other national regulatory agencies on oncology submissions. Health Canada participated in the review process, alongside official observers from European and Japanese authorities. The FDA noted that other agencies might still be reviewing the application. This approval grants Revolution Medicines the authorization for Rasonque in this specific U.S. patient group. The key Phase 3 trial demonstrated a median overall survival of 13.2 months versus 6.7 months with chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.