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The U.S. Food and Drug Administration approved the drug, also known by its generic name daraxonrasib, on August 26, giving patients with advanced pancreatic cancer a new treatment option. Rasonque is a once-daily pill developed by Revolution Medicines that targets RAS proteins involved in tumor growth.

The approval applies to adults with metastatic pancreatic adenocarcinoma who have already received at least one systemic treatment or who are not candidates for multiagent systemic therapy. Pancreatic adenocarcinoma accounts for about 90% to 95% of pancreatic cancer cases in the United States.

How the new pancreatic cancer drug works

Rasonque is designed to target multiple forms of RAS, a protein that plays a key role in the growth of pancreatic tumors. The drug belongs to a class of targeted therapies known as RAS inhibitors.

The treatment is intended for patients with metastatic disease, meaning the cancer has spread from the pancreas to other parts of the body. It is not approved as a first treatment for all pancreatic cancer patients.

What the clinical trial found

The FDA’s approval was based on a randomized clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma.

Patients who received Rasonque had a median overall survival of 13.2 months, compared with 6.7 months among those who received standard chemotherapy. That represents a difference of 6.5 months and is the basis for describing the treatment as nearly doubling median survival.

The results do not mean that every patient taking Rasonque will live twice as long. Median survival is the point at which half of the patients in a study have died, and half remain alive, so individual outcomes can vary.

The FDA regulates food, drugs, medical devices and other products to protect public health in the United States.
The FDA regulates food, drugs, medical devices and other products to protect public health in the United States.FG Trade

What are the side effects?

The FDA reported several common side effects associated with Rasonque. They include rash, diarrhea, inflammation of the mouth, nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite, and hemorrhage.

The agency granted the drug Breakthrough Therapy and Orphan Drug designations and gave the application Priority Review. The approval was issued on August 26, 2026.