Regulatory
FDA approves Revolution Medicines' daraxonrasib for advanced pancreatic cancer
September 2, 2026
Biotech
Regulatory
Key Facts
Signal Type
Regulatory
Industry
Biotech
Companies
Revolution Medicines, Fred Hutch Cancer Center, City of Hope Orange County
Date
September 2, 2026
The FDA granted expedited approval to Revolution Medicines' daraxonrasib, a first-in-class KRAS inhibitor for advanced pancreatic cancer. The drug, to be sold under the brand name Rasonque, will cost approximately $39,800 for a one-month supply.
Approval came more than six months ahead of the FDA's target date. The company-funded study enrolled 500 patients whose metastatic cancer had stopped responding to prior treatment; patients on daraxonrasib lived a median of 13.2 months versus 6.7 months for chemotherapy recipients.
U.S. patients with advanced pancreatic cancer who have progressed on prior treatment now have a new oral option. The drug targets KRAS mutations present in more than 90% of pancreatic cancer cases.
Revolution Medicines, a Redwood City, CA-based biotech, is directly affected as it scales commercial operations. Fred Hutch Cancer Center and City of Hope Orange County, whose clinicians commented on the approval, are also part of the treatment and research ecosystem.
The launch phase creates immediate commercial infrastructure needs for Revolution Medicines and its partners:
Revolution Medicines is studying daraxonrasib in other KRAS-driven tumor types, including lung cancer. The approval may also accelerate competing KRAS programs, as clinicians noted the approach has "opened doors for many other companies."
Expanded access demand, payer coverage decisions, and early launch uptake will signal how quickly the drug displaces chemotherapy in later-line pancreatic cancer.
Source:
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