On August 26, 2026 the U.S. FDA approved RASONQUE for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multi-agent systemic therapy — the first RAS-targeted therapy approved for pancreatic cancer.
On August 26, 2026 the U.S. Food and Drug Administration (FDA) approved Revolution Medicines' daraxonrasib (brand name RASONQUE) for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multi-agent systemic therapy.
The approval is based on the Phase 3 RASolute 302 trial. Among 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy (HR 0.40, 95% CI 0.30–0.53, p < 0.0001); median progression-free survival was 7.2 vs 3.6 months (HR 0.49); and the objective response rate was 30% vs 11%.
The recommended dose is 300 mg orally once daily until disease progression or unacceptable toxicity. Labelled warnings and precautions include dermatologic and soft tissue toxicity, stomatitis, diarrhoea, gastrointestinal perforation, interstitial lung disease/pneumonitis and embryo-fetal toxicity.
The application received Breakthrough Therapy and Orphan Drug designations and was reviewed under the Commissioner's National Priority Voucher (CNPV) and Real-Time Oncology Review (RTOR) pilot programs, with approval coming approximately 6.5 months ahead of the FDA goal date.