FDA Approves Rasonque, First Targeted Pancreatic Cancer Drug — SkimNews

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- The FDA approved daraxonrasib (brand name Rasonque) on Wednesday as a second-line treatment for advanced pancreatic cancer, marking what oncologists describe as the first drug to attack a genetic cause of the aggressive malignancy.
- Rasonque, developed by Revolution Medicines, is the first targeted therapy for advanced pancreatic cancer rather than a traditional cytotoxic chemotherapy.
- Patients receiving Rasonque in the supporting trial achieved a median overall survival of 13.2 months, nearly double the 6.7 months seen in patients on standard chemotherapy.
- Andrew Ko, a gastrointestinal cancer oncologist at the University of California, San Francisco, called the approval "transformative" and "the biggest development we've had in pancreas cancer in decades."
- The approval was supported by a practice-changing clinical trial that read out earlier this year, providing the survival data that underpinned the FDA decision.
Why it matters: Advanced pancreatic cancer patients progressing past first-line chemotherapy had a median survival under seven months — Rasonque nearly doubles that to 13.2 months and is the first drug engineered against the genetic driver of the tumor rather than acting as broad chemotherapy, giving oncologists a fundamentally new tool against a malignancy whose prognosis has barely moved in decades.
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