US FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug
United States, May 1 -- The U.S. Food and Drug Administration is announcing that it issued a "safe to proceed" letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib. The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.FDA regulations allow expanded access to investigational drugs for treatment purposes for larger populations under a treatment protocol or treatment investigational new drug application. Per EAP guidelines, requests for expanded ac...
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