REDWOOD CITY, Calif., August 26, 2026
Revolution Medicines, Inc. has received U.S. Food and Drug Administration (FDA) approval for RASONQUE™ (daraxonrasib), marking a major commercial and regulatory milestone for the company’s RAS(ON) inhibitor platform. The approval makes RASONQUE the first broad RAS-targeted medicine available for adults with metastatic pancreatic adenocarcinoma (PDAC) who have received at least one prior systemic therapy or are not candidates for multiagent chemotherapy. The once-daily oral treatment is approved without the need for a companion diagnostic test, allowing physicians to prescribe the therapy for eligible metastatic PDAC patients regardless of whether a specific RAS mutation has been identified. The FDA decision also establishes Revolution Medicines as a commercial-stage oncology company with its first approved medicine from a new class of multi-selective and mutant-selective RAS-targeted therapies, supporting the company’s long-term strategy to expand its RAS-focused oncology portfolio.
FDA Approval Strengthens Revolution Medicines’ Commercial Oncology Strategy
Revolution Medicines secured the approval based on the successful completion of its global Phase 3 RASolute 302 registrational study, positioning RASONQUE™ as a new treatment option in metastatic pancreatic cancer. The company highlighted that the approval validates its proprietary RAS(ON) tri-complex inhibitor technology, which is designed to directly inhibit active RAS signaling across multiple RAS-driven cancers. Unlike conventional chemotherapy, RASONQUE is an oral targeted therapy that can be taken once daily, reducing the treatment burden associated with intravenous chemotherapy. Alongside the commercial launch, Revolution Medicines has introduced its (ON)Path™ patient support program, which will provide assistance with insurance navigation, financial support and treatment education for eligible patients across the United States. The company is also continuing discussions with global regulatory agencies to expand access to RASONQUE in additional international markets.
Phase 3 Trial Supports Landmark Regulatory Approval
The FDA approval was supported by the Phase 3 RASolute 302 clinical trial, which compared RASONQUE™ with investigator’s choice of standard chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma. The study achieved all primary and key secondary endpoints, demonstrating statistically significant improvements in overall survival, progression-free survival and patient-reported quality of life. According to the trial, RASONQUE reduced the risk of death by 60% compared with chemotherapy, while median overall survival reached 13.2 months versus 6.7 months with standard treatment. The therapy also demonstrated a favorable tolerability profile, with quality-of-life assessments showing delayed deterioration in overall health status and cancer-related pain. While these clinical outcomes represent the evidence supporting the FDA approval, Revolution Medicines emphasized that the broader significance lies in validating direct RAS inhibition as a clinically meaningful treatment strategy in pancreatic cancer.
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Revolution Medicines Expands Global RAS-Targeted Development Program
The approval of RASONQUE™ represents the first commercial success from Revolution Medicines’ broader RAS-targeted oncology pipeline, which includes additional late-stage development programs in non-small cell lung cancer (NSCLC) and other RAS-driven solid tumors. The company is continuing a global Phase 3 development strategy for daraxonrasib while pursuing international regulatory submissions, including ongoing engagement with the European Medicines Agency (EMA). In Europe, daraxonrasib is currently under phased regulatory review and has already received orphan medicinal product designation for pancreatic cancer. Revolution Medicines also noted that RASONQUE was selected for the FDA’s Commissioner’s National Priority Voucher pilot program and is being reviewed through Project Orbis, supporting coordinated international regulatory assessment. With commercial availability now underway in the United States, the company is focused on expanding patient access while advancing its broader portfolio of oral RAS(ON) inhibitors designed to target multiple RAS-driven cancers.
Source: Revolution Medicines press relese
