FDA Approves Rasonque for Metastatic Pancreatic Cancer in Breakthrough Decision

<p>The FDA approved Rasonque, the brand name for daraxonrasib, for the treatment of metastatic pancreatic cancer in September 2026. The approval marks a significant development for a disease that has one of the lowest five-year survival rates of any cancer, with most patients diagnosed at an advanced stage.</p>

<p>Pancreatic cancer is the third leading cause of cancer death in the United States. The five-year survival rate for metastatic pancreatic cancer is below 3 percent. Most patients are diagnosed after the cancer has already spread, leaving few effective treatment options.</p>

<p>Rasonque targets a specific genetic mutation found in a subset of pancreatic cancer patients. Clinical trial data submitted to the FDA showed meaningful improvements in progression-free survival for patients with the targeted mutation compared to standard chemotherapy regimens.</p>

<p>The approval was granted under the FDA's accelerated approval pathway, which allows drugs for serious conditions to reach patients faster based on a surrogate endpoint that is reasonably likely to predict clinical benefit. The manufacturer will be required to conduct confirmatory trials to verify the drug's clinical benefit.</p>

<p>Oncologists said the approval gives them a new tool for a patient population with very limited options. Genetic testing to identify patients with the relevant mutation will be required before prescribing the drug. The FDA recommended that patients with metastatic pancreatic cancer be tested for the mutation at diagnosis to determine eligibility for the new treatment.</p>