Revolution Medicines, Redwood City, Calif., July 22, 2026
Revolution Medicines announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for daraxonrasib, an investigational oral RAS(ON) multi-selective inhibitor, for the treatment of patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The regulatory milestone moves the company closer to potentially introducing a new targeted treatment for one of the deadliest forms of cancer. The NDA is supported by results from the global Phase 3 RASolute 302 trial, which demonstrated significant improvements in overall survival and progression-free survival compared with standard chemotherapy. According to Chief Executive Officer Mark A. Goldsmith, daraxonrasib is designed to directly inhibit RAS, the primary driver of pancreatic cancer, and the positive Phase 3 findings position the therapy as a potential new standard of care for patients with advanced disease.
Phase 3 Trial Demonstrated Strong Survival and Quality-of-Life Benefits
The New Drug Application is based on data from the randomized global Phase 3 RASolute 302 study, which compared daraxonrasib with physician-selected standard-of-care cytotoxic chemotherapy in patients with previously treated metastatic PDAC, regardless of whether tumors carried identified RAS mutations. The study successfully achieved all primary and key secondary endpoints, including unprecedented improvements in overall survival (OS) and progression-free survival (PFS). In addition to extending survival, patients receiving daraxonrasib experienced a manageable safety profile and reported significantly slower deterioration in cancer-related pain, overall health status, and quality of life compared with chemotherapy. The landmark Phase 3 results were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in The New England Journal of Medicine, further highlighting the clinical significance of the findings.
FDA Priority Review and Global Regulatory Progress
The FDA previously granted daraxonrasib both Breakthrough Therapy Designation and Orphan Drug Designation for previously treated metastatic pancreatic cancer. The therapy has also been selected for the FDA Commissioner’s National Priority Voucher pilot program, which is intended to accelerate regulatory review for medicines addressing significant public health needs. Beyond the United States, Revolution Medicines recently announced that the European Medicines Agency (EMA) has initiated a phased review of daraxonrasib, allowing regulatory data to be assessed as it becomes available before submission of a complete marketing authorization application. The investigational therapy has additionally received Orphan Medicine Designation in Europe and has been recognized under the EMA Cancer Medicines Pathfinder project because of its potential to address the substantial unmet medical need in pancreatic cancer treatment.
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Daraxonrasib Expands RAS-Targeted Oncology Pipeline
Daraxonrasib is an investigational oral RAS(ON) multi-selective, noncovalent tri-complex inhibitor designed to suppress RAS signaling by blocking interactions between both wild-type and mutant RAS proteins and their downstream signaling partners. The therapy is intended to treat multiple RAS-driven cancers, including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer. It is currently part of a broader global Phase 3 registrational program consisting of four clinical trials, including the completed RASolute 302 study and three additional ongoing studies in pancreatic cancer and RAS-mutant non-small cell lung cancer. With the FDA now formally reviewing the application, Revolution Medicines has reached a major regulatory milestone that could lead to the first approval of daraxonrasib, offering a promising targeted treatment option for patients with previously treated metastatic pancreatic cancer, a disease that continues to have one of the lowest survival rates among solid tumors.
Source: Revolution Medicines press release
