New FDA-approved pancreatic cancer drug nearly doubles survival in trial

The United States Food and Drug Administration (FDA) has approved a new medication for pancreatic cancer that, according to clinical trial data, nearly doubles the average survival time of patients compared with standard chemotherapy. The drug, daraxonrasib, is a daily pill that will be marketed under the brand name Rasonque by its manufacturer, Revolution Medicines.

Daraxonrasib belongs to a class of targeted therapies designed to block the activity of a mutated gene called KRAS. This mutation is found in more than 90% of pancreatic tumours and is known to spur the growth and spread of cancer cells. By locking onto the abnormal protein produced by the gene, the drug interrupts the signals that tell cancer cells to multiply.

The approval is based on a late-stage clinical trial involving 500 patients with advanced pancreatic cancer. Those who received daraxonrasib had a median overall survival of 13.2 months, while those treated with chemotherapy had a median survival of 6.6 months. The difference represents a near doubling of survival time, which the FDA characterised as a critical advance in a disease that has long defied effective treatment.

Pancreatic cancer is among the deadliest cancers worldwide. In the United States, about 67,000 people are diagnosed with it each year, and it has the highest mortality rate of all major cancers, according to the American Cancer Society. The disease is often detected late because early symptoms, such as abdominal pain or weight loss, are vague and easily overlooked. More than half of patients die within three months of diagnosis, and the five-year survival rate remains below 10%.

The FDA granted daraxonrasib a 'Breakthrough Therapy' designation in 2025, a status reserved for treatments that show substantial improvement over existing therapies for serious or life-threatening conditions. This allowed the agency to review the drug on an accelerated timetable. It was approved six months ahead of the regulatory deadline. In a statement, Dr Angelo de Claro, director of the FDA's Oncology Center of Excellence, said the drug 'showed unprecedented results in an area of high unmet need.'

As with many cancer drugs, daraxonrasib is not without side effects. The most common ones reported in the trial included rash, diarrhoea, nausea, fatigue and vomiting. Severe side effects occurred in 44% of patients taking the drug, compared with 57.5% of those in the chemotherapy group. The FDA said the side-effect profile was manageable and consistent with other drugs in the same class.

Among the patients who have received daraxonrasib is former US Senator Ben Sasse, who announced in December that he had been diagnosed with Stage 4 pancreatic cancer. Sasse is participating in a clinical trial for the drug and has said it has helped shrink his tumours. His case has drawn public attention to the treatment, though individual responses to cancer therapy can vary widely.

The approval provides a new and much-needed option for patients with pancreatic cancer, particularly those with the KRAS mutation. However, medical experts caution that the survival benefit, while meaningful, is not a cure. The drug will need to be studied further to determine its long-term effectiveness and how it works in combination with other treatments. For now, it represents a step forward in what has historically been a very difficult field of oncology.