Revolution Medicines’ RAS(ON) Multi-Selective Inhibitor Daraxonrasib Granted U.S. FDA Orphan Drug Designation in Pancreatic Cancer

Core Insights - Revolution Medicines, Inc. has received Orphan Drug Designation from the FDA for daraxonrasib, a multi-selective inhibitor targeting RAS mutations in pancreatic cancer, addressing a significant unmet medical need [1][2][3] Company Overview - Revolution Medicines is focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes multiple RAS(ON) inhibitors currently in clinical development [7] - The company's lead candidate, daraxonrasib (RMC-6236), is an oral inhibitor designed to suppress RAS signaling by targeting common oncogenic RAS mutations [6][7] Clinical Development - Daraxonrasib is currently being evaluated in a global Phase 3 clinical trial, RASolute 302, for patients with second-line metastatic pancreatic ductal adenocarcinoma (PDAC) [2] - The company plans to initiate two additional Phase 3 trials: one for first-line treatment in metastatic PDAC patients and another for adjuvant treatment in resectable PDAC patients [2] Industry Context - Pancreatic cancer is characterized by late-stage diagnosis and high mortality, with approximately 60,000 new cases and 50,000 deaths annually in the U.S. [4] - The disease is predominantly driven by RAS mutations, with over 90% of PDAC patients harboring these mutations, highlighting the critical need for innovative therapies [5]