FDA Approves New Pancreatic Cancer Treatment Daraxonrasib

The US Food and Drug Administration has approved a treatment for pancreatic cancer that, in clinical trials, nearly doubled the overall survival time for patients.

The drug, daraxonrasib, sold under the brand name Rasonque and manufactured by Revolution Medicines, appears to be a breakthrough in treating one of the world's deadliest cancers.

A late-stage clinical trial with 500 patients found those who took the daily pill had an average survival time of 13.2 months, compared to 6.6 months for those on chemotherapy.

The FDA said the drug provided a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer".

Daraxonrasib helps prevent the spread of cancer by locking onto and shutting off the mutated KRAS gene, which is in more than 90% of pancreatic tumours and spurs cancer growth.

Each year, roughly 67,000 people in the US are diagnosed with pancreatic cancer, which has the highest mortality rate of all major cancers, according to the American Cancer Society.

Pancreatic cancer is often spotted late and is notoriously difficult to treat. More than half of those with pancreatic cancer die within three months of diagnosis.

In 2025, the FDA granted the drug a "Breakthrough Therapy" designation, given to treatments for serious conditions that warrant an expedited review.

The agency then approved the drug six months ahead of the regulatory deadline because it "showed unprecedented results in an area of high unmet need", said Angelo de Claro, director of the the agency's Oncology Center of Excellence.

The most common side effects of the treatment were rash, diarrhoea, nausea, fatigue and vomiting, the FDA said. About 44% of patients on daraxonrasib experienced severe side effects, compared to 57.5% treated with chemotherapy in the trial.

Former US Senator Ben Sasse, who announced in December he had been diagnosed with Stage 4 pancreatic cancer, is in a clinical trial for the drug and has said it has helped shrink his tumours.