MARYLAND / RankWire.AI / – In a recent development, the U.S. Food and Drug Administration has granted approval to Rasonque, also known as daraxonrasib, for specific adult patients with metastatic pancreatic adenocarcinoma. The FDA authorized the once-per-day oral tablet on August 26, 2026, offering a new targeted therapy option. This approval encompasses adults who have undergone at least one systemic treatment and includes those ineligible for multiagent systemic regimens. The medication was developed by Revolution Medicines, targeting the RAS GTPase family.
The decision followed promising data from RASolute 302, a randomized, open-label, multicenter Phase 3 trial involving 500 adults. Participants had metastatic pancreatic adenocarcinoma that progressed after one prior systemic therapy. Researchers randomized 248 patients to receive daraxonrasib and 252 to a physician’s choice of 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.
Additionally, progression-free survival was enhanced across the entire study population. Median progression-free survival stood at 7.2 months for daraxonrasib versus 3.6 months for chemotherapy. The objective response rate was 30% with daraxonrasib, contrasted with 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically significant. The findings support the use of this drug in patients whose metastatic disease has already necessitated systemic intervention.
Targeted therapy focuses on the RAS pathway
Daraxonrasib functions as a RAS inhibitor designed to obstruct active RAS proteins that promote tumor growth. Mutations in RAS are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a recommended dose of 300 milligrams once daily, with treatment ongoing until disease progression or unacceptable toxicity occurs. The FDA approval applies to metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation for prescribing.
Safety data indicated that adverse events occurred in all patients treated with daraxonrasib in the Phase 3 study. Grade 3 or higher adverse events affected 61.8% of patients in the daraxonrasib group and 69.6% in the chemotherapy group. Treatment-related adverse events led to discontinuation in 1.2% and 11.2% of patients, respectively. Common side effects included rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also highlights several serious warnings and precautions.
Accelerated review under priority programs
Among the warnings are skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Embryo-fetal toxicity is also noted in the safety profile. The FDA expedited review through multiple oncology programs, including Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot. The agency announced it approved the application roughly 6.5 months ahead of its target date. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
The review process involved Project Orbis, facilitating collaboration with other national regulatory agencies on oncology submissions. Health Canada participated in the review, with European and Japanese regulators acting as official observers. The FDA indicated that applications may still be under review elsewhere. This approval grants Revolution Medicines the authorization for Rasonque for a defined U.S. patient group. The key Phase 3 data showed a median overall survival of 13.2 months compared to 6.7 months with chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma.