US drug agency approves breakthrough treatment for pancreatic cancer

The US Food and Drug Administration (FDA) has recently approved an innovative treatment for pancreatic cancer, a drug named daraxonrasib or Rasonque manufactured by Revolution Medicines. Clinical trials revealed that patients who took the daily pill experienced nearly double the survival time compared to those on chemotherapy. After 13.2 months of treatment, patients on daraxonrasib had an average survival time of 13.2 months, in contrast to 6.6 months for those on chemotherapy.

This drug is considered a breakthrough in treating one of the deadliest cancers globally. The FDA termed it a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer."

The drug functions by preventing the spread of cancer through its ability to lock onto and shut off the mutated KRAS gene, which exists in over 90% of pancreatic tumours, causing cancer growth. Pancreatic cancer, with the highest mortality rate among major cancers, is often diagnosed late and is notoriously hard to treat. Each year, approximately 67,000 people in the US are diagnosed with this disease, and more than half of them die within three months of diagnosis.

In 2025, the FDA granted the drug a "Breakthrough Therapy" designation, indicating expedited review due to its unprecedented results in a high-need area.

Common side effects of daraxonrasib include rash, diarrhea, nausea, fatigue, and vomiting. However, 44% of patients experienced severe side effects, compared to 57.5% of those treated with chemotherapy in the trial. The FDA's Oncology Center of Excellence Director, Angelo de Claro, cited the drug's unprecedented results in a high-need area as the reason for the approval, which was granted six months ahead of the regulatory deadline.

Former US Senator Ben Sasse, who announced in December he had been diagnosed with Stage 4 pancreatic cancer, is currently in a clinical trial for daraxonrasib. He has reported that it has helped shrink his tumours.