The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer, delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule. This action demonstrates the agency’s commitment to moving with urgency and advancing innovative treatments.

Rasonque, a tablet taken once daily, targets multiple forms of the RAS protein, a key driver of tumor growth in most patients with pancreatic adenocarcinoma. “Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” said Acting FDA Commissioner Kyle Diamantas, J.D.

The approval is for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy. In a clinical trial involving 500 adults, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy. The FDA granted Rasonque Breakthrough Therapy and Orphan Drug designations, with Priority Review.

The most common side effects include rash, diarrhea, stomatitis, nausea, fatigue, vomiting, abdominal pain, edema, decreased appetite, and hemorrhage. The FDA granted the approval to Revolution Medicines, Inc.