The U.S. Food and Drug Administration has approved daraxonrasib, a new drug that has demonstrated a significant increase in overall survival time for pancreatic cancer patients in clinical trials. Sold under the brand name Rasonque and manufactured by Revolution Medicines, the daily pill is considered a breakthrough in treating one of the world's most lethal cancers.
In a late-stage clinical trial involving 500 patients, those who took daraxonrasib experienced an average survival time of 13.2 months, nearly double the 6.6 months seen in patients receiving chemotherapy. The FDA described the drug as providing a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer."
Pancreatic cancer, which affects approximately 67,000 people annually in the U.S., has the highest mortality rate among major cancers, according to the American Cancer Society. The disease is often diagnosed late and is notoriously challenging to treat, with over half of patients dying within three months of diagnosis.
Daraxonrasib functions by targeting the mutated KRAS gene, which is present in more than 90% of pancreatic tumors and drives cancer growth. The drug works by inhibiting this gene, thereby preventing the spread of the cancer.
In 2025, the FDA granted daraxonrasib "Breakthrough Therapy" designation, indicating its potential to treat serious conditions and warranting an expedited review. The agency approved the drug six months ahead of its regulatory deadline, citing its "unprecedented results in an area of high unmet need," according to Angelo de Claro, director of the FDA's Oncology Center of Excellence.
The most frequently reported side effects of daraxonrasib include rash, diarrhea, nausea, fatigue, and vomiting. In the trial, severe side effects were observed in about 44% of patients treated with daraxonrasib, compared to 57.5% of those on chemotherapy.
Former U.S. Senator Ben Sasse, who disclosed his Stage 4 pancreatic cancer diagnosis in December, is participating in a clinical trial for daraxonrasib and has reported that the treatment has helped shrink his tumors.