US FDA approves 'groundbreaking' pancreatic cancer drug

The U.S. Food and Drug Administration (FDA) has approved a new drug for pancreatic cancer, marking a significant advancement in treating one of the deadliest forms of the disease. Daraxonrasib, marketed under the brand name Rasonque and developed by Revolution Medicines, has shown the potential to nearly double patient survival times in clinical trials.

This approval is based on findings from a Phase III clinical trial involving 500 patients. Those who took the daily pill form of daraxonrasib had an average survival of 13.2 months. This contrasts sharply with the average survival of 6.6 months for patients receiving standard chemotherapy. The FDA described the drug as a "critical and new option for patients facing an extremely difficult and hard-to-treat cancer."

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provides a critical and new option for patients facing an extremely difficult and hard-to-treat cancer.

Daraxonrasib works by targeting and disabling the mutated KRAS gene, which is present in over 90% of pancreatic tumors and drives cancer growth. Pancreatic cancer is notoriously difficult to diagnose and treat, with more than half of patients dying within three months of diagnosis. The FDA had previously granted daraxonrasib "Breakthrough Therapy" status in 2025, recognizing its potential in an area of unmet medical need.

Despite its promise, the drug does have side effects, including rash, diarrhea, nausea, fatigue, and vomiting. However, the trial data indicated that severe side effects occurred in about 44% of patients taking daraxonrasib, compared to 57.5% of those on chemotherapy. Former U.S. Senator Ben Sasse, diagnosed with stage 4 pancreatic cancer in December, was among the patients in the clinical trial and reported that the drug helped shrink his tumors.

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has delivered unprecedented results in an area of unmet medical need