US drug agency approves breakthrough treatment for pancreatic cancer
Experts have hailed the drug, daraxonrasib, as a game changer for one of the world's deadliest cancers.
The U.S. Food and Drug Administration (FDA) has given its approval to a novel pancreatic cancer treatment that demonstrated a near-doubling of patients' overall survival time during clinical trials.
Revolution Medicines manufactures the drug, daraxonrasib, marketed as Rasonque, which is being hailed as a significant advancement in combating one of the globe's most lethal cancers.
In a late-stage clinical trial involving 500 patients, those who received the daily oral medication achieved an average survival duration of 13.2 months. This contrasts with an average of 6.6 months for patients undergoing chemotherapy.
The FDA characterized the drug as offering a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer."
Daraxonrasib functions by targeting and deactivating the mutated KRAS gene, which is present in over 90% of pancreatic tumors and drives cancer proliferation, thereby helping to prevent the cancer's spread.
According to the American Cancer Society, approximately 67,000 individuals in the U.S. are diagnosed with pancreatic cancer annually. This cancer carries the highest mortality rate among all major cancers.
Pancreatic cancer is frequently detected at advanced stages and is notoriously challenging to treat. Over half of those diagnosed with the disease succumb within three months of their diagnosis.
In 2025, the FDA designated the drug as a "Breakthrough Therapy," a status granted to treatments for serious conditions that qualify for an accelerated review process.
The agency's Oncology Center of Excellence director, Angelo de Claro, stated that the drug's approval came six months ahead of the regulatory deadline because it "showed unprecedented results in an area of high unmet need."
The FDA reported that the most frequently observed side effects of the treatment included rash, diarrhea, nausea, fatigue, and vomiting. Approximately 44% of patients receiving daraxonrasib experienced severe side effects, compared to 57.5% of those treated with chemotherapy in the trial.
Former U.S. Senator Ben Sasse, who disclosed his diagnosis of Stage 4 pancreatic cancer in December, is participating in a clinical trial for the drug and has indicated that it has contributed to the shrinkage of his tumors.