FDA Approves Daraxonrasib for Advanced Pancreatic Cancer

The FDA approved daraxonrasib for advanced pancreatic cancer on Wednesday, after trial data showed longer survival than standard chemotherapy.

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FDA Approves Daraxonrasib for Advanced Pancreatic Cancer

The Food and Drug Administration approved daraxonrasib on Wednesday for advanced pancreatic cancer. The drug, made by Revolution Medicines and sold as Rasonque, is the first to attack a genetic cause of the disease.

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Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco, said, "It will be transformative in the way we treat pancreas cancer. It’s the biggest development we’ve had in pancreas cancer in decades". He also said, "I’m so thankful for this as an advance for our patients."

Rasonque trial data

The approval rested on a clinical trial that read out earlier this year. In that study, patients with advanced pancreatic cancer who received Rasonque as a second-line treatment lived a median 13.2 months, compared with 6.7 months for patients who received standard chemotherapy.

That gap is the clearest measure in the record here of why the approval mattered to doctors treating the disease. It gives patients and clinicians a new option after first treatment has not worked, with the FDA now allowing the drug to be used in that setting.

Andrew Ko on pancreas cancer

Ko’s comments put the scale of the decision in plain terms. He tied the approval to a broader change in how pancreas cancer is treated, while also making clear that the advance is measured against a disease that remains highly lethal.

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The source’s central complication is also the one patients will notice most: the treatment extends life, but the median survival figures are still counted in months, not years. For people who have already moved beyond first-line therapy, the practical change is access to a drug now cleared by the FDA and marketed as Rasonque.

How quickly doctors adopt it in routine care is the open question left by the approval itself.

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News writer with 11 years covering breaking stories, politics, and community affairs across the United States. Associated Press contributor.