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FDA Approves Rasonque for Metastatic Pancreatic Cancer

8/28/2026

Summary

FDA Approves Rasonque

The U.S. Food and Drug Administration approved the oral drug Rasonque for metastatic pancreatic cancer.
A Phase 3 RASolute 302 trial with 500 patients showed median survival 13.2 months versus 6.7 months.
The trial indicated a 60 percent reduction in death risk for patients taking Rasonque.
Severe side effects occurred in 44 percent of Rasonque patients versus 57.5 percent on chemotherapy.
Rasonque’s wholesale price is about $39,800 for a 30-day supply in the United States.

Summary

FDA Grants Breakthrough

The FDA granted daraxonrasib Breakthrough Therapy, Orphan Drug, and Priority Review designations.
The drug entered the Commissioner’s National Priority Voucher pilot, accelerating its review timeline.
In May, the FDA issued a safe-to-proceed letter for expanded-access treatment before formal approval.
Rasonque was reviewed under the FDA’s Project Orbis, enabling simultaneous assessment by foreign regulators.
ESMO incorporated trial data into guidelines, recommending daraxonrasib for previously treated metastatic PDAC patients.

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FDA Approves Rasonque

The U.S. Food and Drug Administration approved the oral drug Rasonque for metastatic pancreatic cancer.
A Phase 3 RASolute 302 trial with 500 patients showed median survival 13.2 months versus 6.7 months.
The trial indicated a 60 percent reduction in death risk for patients taking Rasonque.
Severe side effects occurred in 44 percent of Rasonque patients versus 57.5 percent on chemotherapy.
Rasonque’s wholesale price is about $39,800 for a 30-day supply in the United States.

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