FDA Approves Rasonque (daraxonrasib), First Targeted Therapy for Most Common Form of Metastatic Pancreatic Cancer

The U.S. Food and Drug Administration on Wednesday approved Rasonque, or daraxonrasib, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy, marking a rare advance against one of the deadliest major cancers. The agency described the drug, approved for Revolution Medicines, as the first targeted therapy for the most common form of metastatic pancreatic cancer and cleared it after a trial showed patients lived markedly longer than those given standard chemotherapy.

The approval was backed by RASolute 302, a randomized, open-label, multicenter Phase 3 trial that enrolled about 500 adults with previously treated metastatic pancreatic adenocarcinoma. In that study, median overall survival was 13.2 months with daraxonrasib, compared with 6.7 months with standard chemotherapy. The company and trial materials also reported a hazard ratio of 0.40 in the intent-to-treat population, with a p-value of less than 0.0001. The results were presented in a plenary session at the 2026 American Society of Clinical Oncology annual meeting and published in the New England Journal of Medicine.

Why that matters is straightforward: pancreatic cancer has long had few effective treatment options, especially after an initial treatment stops working. Pancreatic ductal adenocarcinoma, the disease covered by the approval, accounts for more than 90% of pancreatic cancers. U.S. estimates for 2026 put the toll at about 67,530 new pancreatic cancer cases and 52,740 deaths, according to the National Cancer Institute’s SEER program.

The decision also stands out because RAS has been a major cancer target for decades, but pancreatic cancer has been hard to treat with earlier KRAS-targeted drugs. Those earlier medicines generally focused on the KRAS G12C mutation, which is uncommon in pancreatic cancer. Daraxonrasib is intended for a broader set of RAS-driven tumors common in this disease. The FDA said the drug had received Breakthrough Therapy designation, Orphan Drug designation and Priority Review. The agency also said the application was reviewed under the commissioner’s National Priority Voucher pilot program and was approved 6.5 months before the user-fee deadline.

For patients, the treatment is comparatively simple to take: Rasonque is an oral tablet taken once daily. But like other cancer drugs, it can bring significant side effects. The FDA said the most common adverse events were rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage.

Kyle Diamantas, the acting FDA commissioner, called the approval “a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer.” Angelo de Claro, a director at the FDA’s Oncology Center of Excellence, put the significance more bluntly: “This drug showed unprecedented results in an area of high unmet need.”