FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer

The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma.

Rasonque is a tablet taken once daily that targets multiple forms of the RAS protein, a key driver of tumor growth in most patients with this disease.

The approval applies to adults with metastatic disease who have received at least one prior systemic therapy or who are not candidates for multi‑agent systemic therapy.

The agency highlighted the rapid review process and the need for new options in a cancer that represents about 90‑95% of the roughly 67,000 new pancreatic cancer cases diagnosed in the United States each year.