In brief
The FDA has authorized daraxonrasib, marketed as Rasonque, after clinical trials showed it extended survival from 6.6 to 13.2 months in pancreatic cancer patients. The drug, made by Revolution Medicines, targets the mutated KRAS gene that drives over 90% of tumours. It earned a Breakthrough Therapy designation in 2025 and was cleared six months ahead of the normal schedule. Side‑effects were common but less severe than with standard chemotherapy. Senator Ben Sasse, a Stage 4 patient, noted tumour shrinkage during trials.
US Food and Drug Administration has approved a treatment that nearly doubled overall survival time for pancreatic cancer patients in clinical trials.
The drug, daraxonrasib—sold under the brand name Rasonque—is manufactured by Revolution Medicines and represents a breakthrough against the world’s deadliest cancer.
In a late‑stage study involving 500 patients, the daily pill yielded a mean survival of 13.2 months, compared with 6.6 months for those receiving conventional chemotherapy.
The FDA said the drug offers a “critical new option for patients facing an extraordinarily difficult and historically hard‑to‑treat cancer.”
Daraxonrasib works by locking onto and shutting off the mutated KRAS gene, which appears in over 90% of pancreatic tumours and drives cancer growth.
Each year, about 67,000 U.S. residents are diagnosed with pancreatic cancer, which has the highest mortality rate among major cancers (American Cancer Society). The disease is often detected late, and more than half of patients die within three months of diagnosis.
Granted a Breakthrough Therapy designation in 2025, the drug was approved six months ahead of the original regulatory deadline, reflecting “unprecedented results in an area of high unmet need” (Angelo de Claro, FDA Oncology Center of Excellence).
Common side‑effects of Rasonque include rash, diarrhoea, nausea, fatigue and vomiting. 44% of patients experienced severe side‑effects, compared with 57.5% on chemotherapy.
Former U.S. Senator Ben Sasse, diagnosed with stage 4 pancreatic cancer in December, is currently in a clinical trial of the drug and reports tumour shrinkage.
For more details, view the official FDA statement and the full clinical trial data.
