FDA approves Rasonque for metastatic pancreatic cancer

The U.S. Food and Drug Administration granted approval on Wednesday to Revolution Medicines’ oral therapy Rasonque for patients with advanced, metastatic pancreatic cancer, marking the first new indication for the disease in several years. The decision follows a pivotal Phase III trial that demonstrated the once‑daily pill doubled overall survival compared with standard care, extending median survival from roughly six to twelve months in a population that had previously exhausted all approved options.

The approval provides clinicians with a novel, targeted treatment for a malignancy that accounts for roughly 3 % of all cancers in the United States yet remains the third leading cause of cancer death. Rasonque, which targets a specific molecular pathway implicated in tumor growth, is now available for prescription and will be incorporated into treatment guidelines for metastatic pancreatic cancer, offering patients an additional line of therapy after chemotherapy and radiation have failed.