FDA Approves New Treatment for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration approved Rasonque, a new oral treatment for advanced pancreatic cancer, after a clinical trial showed substantial improvements in survival compared with standard chemotherapy. The approval applies to adults with metastatic pancreatic adenocarcinoma whose disease progressed after at least one prior treatment, or who cannot receive combination therapy.
Rasonque, also known as daraxonrasib, was developed by Revolution Medicines. The once-daily pill blocks RAS proteins, which contribute to tumor growth. The FDA completed its expedited review about six and a half months before its target date.
The agency’s decision relied on a study of 500 patients with metastatic pancreatic cancer that had worsened following earlier treatment. Median overall survival was 13.2 months among patients receiving daraxonrasib, compared with 6.7 months for those receiving standard chemotherapy. The treatment also approximately doubled the period before disease progression and reduced the risk of death by 60 percent during the trial.
Cancer specialists described the results as a major development for a disease that has seen limited therapeutic progress. Andrew Ko, a gastrointestinal cancer specialist at the University of California, said the drug could significantly change pancreatic cancer treatment. Rachna Shroff of the University of Arizona Cancer Center similarly emphasized the study’s potential importance for patients.
Pancreatic cancer remains among the deadliest cancers. The National Cancer Institute estimates that 67,530 Americans will be diagnosed in 2026, while 52,740 will die from the disease. The five-year relative survival rate is 13.3 percent.
Common side effects reported with Rasonque include rash, diarrhea, mouth inflammation, nausea, fatigue, vomiting, abdominal pain, swelling, reduced appetite, and hemorrhage. The approval provides another option for eligible patients, though treatment decisions will depend on individual medical circumstances and assessment of potential benefits and risks. Further follow-up will help clarify long-term outcomes and the treatment’s use in broader patient populations.
