The Food and Drug Administration approved RASONQUE (daraxonrasib), the first targeted therapy in a new class of RAS inhibitors, for adults with metastatic pancreatic adenocarcinoma who have already received at least one line of systemic therapy or who are not candidates for multiagent systemic therapy. The approval was granted to Revolution Medicines, Inc. on August 26, 2026, according to the FDA drug-approval notice.
Pancreatic adenocarcinoma is the most common form of pancreatic cancer, accounting for roughly 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed in the United States each year, according to the National Cancer Institute figures cited in the FDA press announcement. The disease is typically detected late and has historically had few treatment options after first-line chemotherapy.
Efficacy was evaluated in RASolute 302 (NCT06625320), a randomized, open-label, multicenter trial in patients with metastatic pancreatic adenocarcinoma whose disease had progressed after one prior line of systemic therapy. According to the FDA drug-approval notice, 500 patients were randomized 1:1 to receive either daraxonrasib or physician’s choice of standard-of-care chemotherapy. Median overall survival was 13.2 months in the daraxonrasib arm and 6.7 months in the standard-of-care arm (hazard ratio 0.40; p-value less than 0.0001). Median progression-free survival was 7.2 months versus 3.6 months (hazard ratio 0.49; p-value less than 0.0001). Objective response rate was 30% versus 11% (p-value less than 0.0001).
According to the Revolution Medicines press release, RASONQUE is an oral tablet and represents the first approved cancer medicine from a new class of RAS(ON) multi-selective and mutant-selective inhibitors. The company’s release describes RASONQUE as the first broad RAS-targeted medicine in metastatic pancreatic cancer and states that the drug is now available by prescription in the United States, with support offered through its (ON)PATH patient-support program.
According to the FDA drug-approval notice, RASONQUE received Breakthrough Therapy designation, Orphan Drug designation, and Priority Review. The review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence, and included collaboration with Health Canada; the European Medicines Agency and Japan’s Pharmaceuticals and Medical Devices Agency were official observers. The approved prescribing information includes warnings and precautions for skin and soft-tissue toxicity, mouth and gastrointestinal disorders, diarrhea, gastrointestinal perforation, interstitial lung disease and pneumonitis, and embryo-fetal toxicity.
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