Federal regulators cleared the first RAS-targeted therapy for advanced pancreatic cancer on August 26, 2026, giving oncologists a new option against a disease that kills more than 50,000 Americans each year.
The drug, sold by Revolution Medicines as Rasonque under the generic name daraxonrasib, is a once-daily pill for adults with metastatic pancreatic adenocarcinoma who have already received at least one prior systemic therapy or cannot tolerate combination chemotherapy.
In the phase 3 RASolute 302 trial of 500 patients, median overall survival reached 13.2 months on daraxonrasib compared with 6.7 months on standard chemotherapy, a 60 percent reduction in the risk of death.
Why pancreatic cancer has resisted progress
The American Cancer Society projects 67,530 new US pancreatic cancer diagnoses in 2026 and 52,740 deaths, and the five-year relative survival rate has stalled at 13 percent.
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Because early tumors rarely cause symptoms, most patients are diagnosed only after the disease has spread and the warning signs of pancreatic cancer finally emerge.
Mutations in the RAS family of proteins drive tumor growth in about 90 percent of pancreatic cancers, but RAS was long considered impossible to target because of its smooth surface.
Daraxonrasib works as a molecular glue, binding RAS to a chaperone protein called cyclophilin A and shutting down the growth signal.
What the trial actually found
Progression-free survival, meaning time before tumors grew again, was 7.2 months on daraxonrasib versus 3.6 months on chemotherapy. About 32 percent of patients on the drug had measurable tumor shrinkage, roughly triple the chemotherapy rate.
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At 12 months, 53 percent of daraxonrasib patients were still alive, compared with 19 percent of those on chemotherapy alone, according to Dana-Farber Cancer Institute, which co-led the trial.
Brian M. Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber, said in a statement that the approval "represents a landmark advance for patients with metastatic pancreatic cancer."
Side effects patients should know about
Serious adverse reactions occurred in 30 percent of Rasonque patients, according to the prescribing information. Rash was the most common problem, affecting 85 percent of patients. Stomatitis, which is inflammation of the mouth, hit 53 percent.
Diarrhea, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite and hemorrhage were also common. About 1 percent of patients stopped treatment because of side effects.
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What to ask an oncologist
Patients or family members considering the drug should ask whether their tumor carries a RAS mutation, whether prior therapies fit the label, and how the side-effect profile compares with continued chemotherapy.
The FDA label limits Rasonque to adults with metastatic disease who have already had one line of systemic therapy or cannot tolerate multi-drug regimens.
FDA Acting Commissioner Kyle Diamantas said in the agency's approval announcement that the decision "provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer."
The FDA cleared Rasonque under priority review roughly six and a half months before the user-fee deadline. Revolution Medicines said the tablet is available in the United States immediately through specialty oncology distribution.
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This article is made and published by Emil Martesen, who may have used AI in the preparation.