In brief
The FDA’s approval of daraxonrasib (Rasonque) follows a late‑stage trial showing the drug cut median survival from 6.6 to 13.2 months in 500 patients. The treatment targets the KRAS gene, mutated in over 90% of pancreatic tumours, and offers a new hope where few options exist. Side‑effect rates were lower than chemotherapy, with only 44 % of patients experiencing severe symptoms. Former senator Ben Sasse, undergoing a clinical trial, reports tumour shrinkage.
U.S. FDA has approved daraxonrasib, sold as Rasonque, following a late‑stage trial that showed the drug nearly doubled overall survival time for patients.
In the study of 500 patients, those who took the daily pill lived an average 13.2 months, compared with 6.6 months for those on standard chemotherapy.
The treatment works by targeting the KRAS gene, which is mutated in over 90% of pancreatic tumours and drives cancer growth.
Pancreatic cancer has the highest mortality rate among major cancers, with about 67,000 new cases in the U.S. each year and more than half dying within three months of diagnosis.
The FDA gave the drug a Breakthrough Therapy designation in 2025 and approved it six months ahead of schedule, citing unprecedented results in an area of high unmet need.
Side effects were fewer than chemotherapy: rash, diarrhoea, nausea, fatigue and vomiting, and 44 % of patients experienced severe symptoms versus 57.5 % on chemo.
Former U.S. senator Ben Sasse, diagnosed with Stage‑4 pancreatic cancer, is in a trial of the drug and reports tumour shrinkage.
Experts say this marks a major milestone, offering a critical new option when few therapies exist.
