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Policy & Regulation

FDA Approves Landmark Pancreatic Cancer Drug That Improves Survival

FDA approves daraxonrasib, a first-of-a-kind pancreatic cancer drug that nearly doubles survival time, according to NPR.

AI News Feed · 2026-08-27 20:34

The company announced that a one-month supply would cost approximately $39,800. In a company-funded study of 500 patients whose metastatic cancer had stopped responding to prior treatment, patients randomly assigned to the new drug lived for a median of 13.2 months compared with 6.7 months for those receiving chemotherapy. Side effects included skin rash, mouth sores, diarrhea and other digestive issues, though the drug produced fewer severe side effects than chemotherapy.

Dr. Andrew Coveler of the Fred Hutch Cancer Center called the approval one of the most anticipated he could think of, saying the medicine is not a cure but a significant improvement.

Pancreatic cancer is among the most deadly forms because it is often hard to detect before spreading. The American Cancer Society estimates about 67,000 new cases will be diagnosed in the United States this year and more than 52,000 people will die from the disease. The five-year overall survival rate is 13%.

The drug drew public attention earlier this year when former Sen. Ben Sasse, R-Neb., described on CBS' "60 Minutes" how he has had less pain while taking it. A surge in public interest led the FDA to allow "expanded access" before official approval for patients who met certain criteria. FDA regulators noted they approved the drug more than six months ahead of their target date.

Acting FDA Commissioner Kyle Diamantas said in a statement: "It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible."

The new drug targets mutations in the RAS gene family, particularly KRAS mutations, which are critical in fueling pancreatic cancer. The mutated protein's structure previously made it hard for drugs to bind, and it was long considered "undruggable." Doctors hope the drug may open doors for other cancers, with many experimental drugs in development. Dr. Pashtoon Kasi of City of Hope Orange County said, "I think this has opened doors for many other companies. Downstream I think there are going to be a lot more trials looking at this approach in other tumor types." Revolution Medicines, based in Redwood City, California, is studying the technology for lung cancer and other forms.