# Ne oldu?

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. The approval was granted 6.5 months before the user fee deadline.

# Ayrıntılar

Rasonque is indicated for adults with metastatic pancreatic adenocarcinoma who have received prior systemic therapy or are not candidates for multiagent systemic therapy. In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, Rasonque improved median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy. The trial demonstrated a statistically significant and clinically meaningful improvement in survival. Rasonque, a tablet taken once daily, targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, which arises from cells lining the ducts of the pancreas.

# Neden önemli?

This approval marks the first targeted therapy available for metastatic pancreatic adenocarcinoma in patients who have progressed on or are ineligible for standard chemotherapy. The median overall survival benefit of 6.5 months represents a meaningful advancement in a disease with historically limited treatment options. The FDA granted the therapy Breakthrough Therapy and Orphan Drug designations, reflecting its potential to address an unmet medical need in pancreatic cancer.

# Sırada ne var?

The FDA’s Oncologic Drugs Advisory Committee will review real-world evidence and long-term safety data as post-marketing requirements. Patients and clinicians should discuss the role of Rasonque in the context of prior treatment history and individual tolerance. Continued monitoring of survival outcomes and adverse event profiles will shape future guideline recommendations.