On Aug. 26, 2026, the U.S. Food and Drug Administration (FDA) 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, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families.

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.  

The drug, called daraxonrasib, will be sold under the brand name Rasonque. The FDA’s approval was supported by a practice-changing clinical trial that read out earlier this year. Patients with advanced pancreatic cancer who received Rasonque as a second-line treatment achieved a median overall survival of 13.2 months, compared to 6.7 months for patients offered standard chemotherapy. 

The approval is for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

Approximately 90% to 95% of the 67,000 new cases of pancreatic cancer diagnosed in the United States each year are pancreatic adenocarcinoma, according to the National Cancer Institute. Despite representing roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths, owing to its typically late detection, aggressive disease course, and historically limited treatment options.

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.