MARYLAND / RankWire.AI / – The U.S. Food and Drug Administration has given the green light to Rasonque, also known as daraxonrasib, for use in certain adults battling metastatic pancreatic adenocarcinoma. The FDA authorized the once-daily tablet on August 26, 2026, offering a new targeted option for patients. This approval extends to adults who have previously undergone at least one systemic therapy and to those who are not suitable candidates for multi-agent systemic treatment. Revolution Medicines developed this medication, which specifically targets the RAS GTPase family involved in cancer progression.
The decision followed positive data from RASolute 302, a multicenter, randomized, open-label Phase 3 trial involving 500 adult participants. These individuals had metastatic pancreatic adenocarcinoma that had advanced following one prior systemic therapy. Researchers allocated 248 patients to receive daraxonrasib, while 252 received physician-chosen standard chemotherapy. Results showed 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 saw notable improvement. The median progression-free survival was 7.2 months for patients on daraxonrasib versus 3.6 months for those on standard chemotherapy. The objective response rate was observed at 30% in the daraxonrasib group, compared to 11% in the chemotherapy group. These differences in overall survival, progression-free survival, and response rate were statistically meaningful. The findings support using this drug in patients whose metastatic disease has already necessitated systemic treatment.
Targeted treatment interferes with RAS signaling pathway
Daraxonrasib functions as a RAS inhibitor, specifically designed to block the active forms of RAS proteins that promote tumor growth. Mutations in RAS genes are present in over 90% of pancreatic ductal adenocarcinomas. The medication is administered orally at a dose of 300 milligrams once daily, with treatment continuing until disease progression or intolerable side effects occur. The FDA’s approval applies to metastatic pancreatic adenocarcinoma and does not require a specific RAS mutation for prescribing.
Safety profiles from the Phase 3 trial indicated that adverse events occurred across all patients treated with daraxonrasib. 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 caused discontinuation in 1.2% of daraxonrasib patients and 11.2% of those on chemotherapy. Common side effects encompass rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and bleeding. The prescribing information also includes several serious warnings and precautions.
Expedited FDA review process facilitated approval
The FDA’s review process included several priority programs, which addressed safety concerns such as skin and soft tissue toxicity, oral disorders, diarrhea, gastrointestinal perforation, and interstitial lung disease or pneumonitis. Embryo-fetal toxicity was also highlighted as a warning. The agency expedited the review through initiatives like Real-Time Oncology Review and the Commissioner’s National Priority Voucher pilot, ultimately approving the application approximately 6.5 months ahead of its scheduled review goal. Additionally, daraxonrasib received Breakthrough Therapy and Orphan Drug designations.
The application was also evaluated via Project Orbis, enabling collaboration with other national regulatory agencies on oncology drugs. Health Canada participated in the review, with European and Japanese authorities observing as official reviewers. The FDA noted that other agencies may still be in the review process. This approval grants Revolution Medicines the authorization to market Rasonque for the designated U.S. patient group. Notably, the key Phase 3 outcome for patients with previously treated metastatic pancreatic adenocarcinoma was a median overall survival of 13.2 months, versus 6.7 months for chemotherapy.