FDA approves pancreatic cancer drug that nearly doubles survival time
What's the story
The US Food and Drug Administration (FDA) has approved a new treatment for pancreatic cancer, a disease known for its high mortality rate. The drug, daraxonrasib, sold under the brand name Rasonque and produced by Revolution Medicines, was found to nearly double the overall survival time of patients in clinical trials. In a late-stage trial with 500 patients, those who took the daily pill had an average survival time of 13.2 months compared to 6.6 months for chemotherapy recipients.
Mechanism of action
Daraxonrasib targets mutated KRAS gene
Daraxonrasib works by preventing the spread of cancer.
It does this by targeting and shutting off the mutated KRAS gene, found in over 90% of pancreatic tumors and responsible for fueling cancer growth.
The FDA described the drug as a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer."
Approval process
Drug approved 6 months ahead of deadline
The FDA had granted daraxonrasib a "Breakthrough Therapy" designation in 2025, which is given to treatments for serious conditions that warrant expedited review.
The agency approved the drug six months ahead of the regulatory deadline as it "showed unprecedented results in an area of high unmet need," said Angelo de Claro, director of the agency's Oncology Center of Excellence.
Common side effects included rash, diarrhea, nausea, fatigue, and vomiting.
Disease impact
One-month supply to cost $39,800
Pancreatic cancer is often diagnosed late and is notoriously difficult to treat.
More than half of those with this type of cancer die within three months of diagnosis.
In the US, some 67,000 people are diagnosed with pancreatic cancer annually.
A one-month supply of daraxonrasib will cost about $39,800, Revolution Medicines announced.