MARYLAND / RankWire.AI / – U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for select adult patients suffering from metastatic pancreatic adenocarcinoma. The agency authorized the once-per-day tablet on August 26, 2026, providing a new targeted therapeutic option for patients. This approval includes adults who have undergone at least one prior systemic therapy and also those ineligible for multiagent systemic treatment. The drug was developed by Revolution Medicines and targets the RAS GTPase family.
This clearance was based on data from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that had advanced after one previous systemic treatment. Researchers assigned 248 patients to receive daraxonrasib, while 252 received physician-selected standard chemotherapy. 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.
In addition, progression-free survival was notably better across the entire study group. Median progression-free survival reached 7.2 months with daraxonrasib, versus 3.6 months with standard chemotherapy. The objective response rate stood at 30% for the daraxonrasib group, while it was 11% for the chemotherapy group. The differences observed in overall survival, progression-free survival, and response rate were statistically meaningful. These findings support the medication’s use in patients whose metastatic disease has already necessitated systemic therapy.
Targeted Therapy Focuses on RAS Signaling
Daraxonrasib functions as a RAS inhibitor, aiming to suppress the active forms of RAS proteins responsible for tumor proliferation. Mutations in RAS are found in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a suggested dose of 300 milligrams once daily, with treatment continuing until disease progression or intolerable adverse effects. The approval pertains to metastatic pancreatic adenocarcinoma without requiring a specific RAS mutation in the prescribed indication.
Safety data indicated that adverse events affected all participants who received daraxonrasib during 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 resulted in discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also contains multiple serious warnings and precautions.
Expedited Review Processes Facilitated FDA Approval
The safety warnings encompass skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Additionally, the label cautions about embryo-fetal toxicity. The FDA’s review utilized several accelerated oncology review pathways, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced that approval was granted approximately 6.5 months prior to the scheduled goal date. Moreover, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
For international collaboration, the FDA employed Project Orbis, which enables joint review efforts with other national regulators on oncology submissions. Health Canada participated in the review process, with European and Japanese regulators acting as official observers. The FDA also noted that applications might still be under review in other jurisdictions. This approval grants Revolution Medicines the authorization for Rasonque in this specific U.S. patient group. The key Phase 3 trial reported a median overall survival of 13.2 months for the daraxonrasib group versus 6.7 months with chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.