US FDA approves Revolution Medicines' pancreatic cancer drug
The once-daily pill nearly doubled median survival in a 500-patient trial and offers a new option after prior chemotherapy.
- On Aug 26, The FDA approved Rasonque, a new drug from Revolution Medicines for adults with advanced pancreatic cancer who have received prior treatment.
- Designed as a once-daily pill, Rasonque functions by blocking several forms of the RAS protein, which drives tumor growth in pancreatic cancer.
- Data from a study of 500 adults showed the drug improved median overall survival to 13.2 months, compared with 6.7 months on standard chemotherapy.
- Andrew Ko, a medical oncologist at the University of California, San Francisco, called it "the biggest development we've had in pancreas cancer in decades."
- Revolution did not immediately respond to a request from Reuters for comment on the drug's pricing and availability following the regulatory clearance.
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Revolution Medicines, Inc. (RVMD) Discusses FDA Approval of RASONQUE for Metastatic Pancreatic Cancer and Implications for RAS-Driven Therapy Transcript
Revolution Medicines, Inc. (RVMD) Discusses FDA Approval of RASONQUE for Metastatic Pancreatic Cancer and Implications for RAS-Driven Therapy August 26,...
The FDA had previously granted Daraxonrasib the designation of "Innovative Therapy," and accelerated its review
FDA approves pancreatic cancer drug that’s shown to improve survival
WASHINGTON, D.C. — The Food and Drug Administration on Wednesday approved a groundbreaking new drug for advanced pancreatic cancer, offering US patients a more effective treatment against one of the deadliest types of cancer.FDA officials gave expedited approval to the first-of-a-kind pill, called daraxonrasib, which blocks a mutated protein that fuels tumor growth in more than 90 percent of pancreatic cancer cases. It’s an approach that previou…
FDA Nod for Daraxonrasib Marks First RAS-Targeted Advance in Metastatic Pancreatic Cancer
Pancreatic cancer has long carried one of the bleakest outlooks in oncology. Most patients receive a diagnosis after the disease has spread. Standard chemotherapy offers limited gains. Survival often measures in months. Yet on August 26, 2026, the FDA approved Rasonque (daraxonrasib), an oral once-daily RAS inhibitor from Revolution Medicines. The decision arrived 6.5 months ahead of schedule. It delivers the first approved therapy that directly…
FDA approves landmark pancreatic cancer drug
What happenedThe Food and Drug Administration on Wednesday approved a first-of-its-kind drug for advanced pancreatic cancer, one of the deadliest types of cancer and among the hardest to treat. The FDA’s expedited approval of daraxonrasib, a daily pill developed by Revolution Medicines and sold as Rasonque, followed a clinical trial in which patients on the drug lived a median 13.2 months, twice as long as those who underwent chemotherapy, and w…
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