The U.S. Food and Drug Administration has approved a treatment for pancreatic cancer that, in clinical trials, nearly doubled patients’ overall survival time. The drug, daraxonrasib, sold under the brand name Rasonque and manufactured by Revolution Medicines, appears to be a breakthrough in the treatment of one of the world’s deadliest cancers. A late-stage clinical trial of 500 patients found that those who took the daily pill had an average survival time of 13.2 months, compared with 6.6 months for those who received chemotherapy. The FDA said the drug provided a “critical new option for patients facing an extraordinarily difficult and historically difficult cancer to treat.” Daraxonrasib helps prevent the spread of cancer by blocking and inactivating the mutated KRAS gene, which is found in more than 90% of pancreatic tumors and stimulates cancer growth. Each year, about 67,000 people in the U.S. are diagnosed with pancreatic cancer, which has the highest mortality rate of all major cancers, according to the American Cancer Society. Pancreatic cancer is often detected late and is notoriously difficult to treat. More than half of people with pancreatic cancer die within three months of diagnosis. In 2025, the FDA granted the drug “Breakthrough Therapy” designation, given to treatments for serious conditions that warrant expedited review. The agency then approved the drug six months before the regulatory deadline because it “showed unprecedented results in an area of high unmet need,” said Angelo de Claro, director of the agency’s Oncology Center of Excellence. The most common side effects of the treatment were rash, diarrhea, nausea, fatigue and vomiting, the FDA said. About 44% of patients treated with daraxonrasib experienced serious side effects, compared to 57.5% treated with chemotherapy in the trial. Former U.S. Senator Ben Sasse, who announced in December that he had been diagnosed with stage 4 pancreatic cancer, is in a clinical trial of the drug and has said it has helped shrink his tumors.
