US regulator approves breakthrough drug for pancreatic cancer

The US Food and Drug Administration (FDA) has cleared a new drug for pancreatic cancer that could mark a major step forward against one of the deadliest forms of the disease. The medication, daraxonrasib, will be sold under the brand name Rasonque and was developed by Revolution Medicines.

In a large late-stage trial involving 500 patients, those taking the daily pill survived an average of 13.2 months, compared with just 6.6 months for patients treated with chemotherapy — roughly double the survival time.

FDA officials described the drug as offering a critical new option for patients confronting an unusually difficult and historically hard-to-treat cancer. The treatment works by targeting and disabling the mutated KRAS gene, which drives cancer growth and is present in more than 90% of pancreatic tumours.

Scale of the disease

According to the American Cancer Society, roughly 67,000 people in the US are diagnosed with pancreatic cancer each year, and it carries the highest mortality rate of any major cancer. The disease is frequently caught late, and more than half of patients die within three months of diagnosis.

The FDA granted the drug Breakthrough Therapy status in 2025, a designation reserved for treatments addressing serious conditions that qualify for accelerated review. The agency ultimately approved the drug six months ahead of schedule, citing what Angelo de Claro, director of the FDA's Oncology Center of Excellence, called unprecedented results in an area of significant unmet medical need.

The most frequently reported side effects included rash, diarrhoea, nausea, fatigue and vomiting. About 44% of patients on the new drug experienced severe side effects, compared with 57.5% of those who received chemotherapy.

Former US Senator Ben Sasse, diagnosed with stage four pancreatic cancer in December, is among the patients enrolled in a clinical trial for the drug. He has said it has helped shrink his tumours.