Today, 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 access must be submitted to the sponsor by physicians licensed in the U.S. on behalf of eligible patients.
“Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease.”
Daraxonrasib is a RAS inhibitor designed to inhibit a protein (RAS) that is mutated in most pancreatic cancer tumors.
The company said on April 13 that it intends to submit a new drug application for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot program. The FDA granted a national priority voucher to daraxonrasib, also called RMC-6236, in October 2025.
The FDA previously granted Breakthrough Therapy and Orphan Drug designations to daraxonrasib.
|
