Revolution Medicines Announces FDA Breakthrough Therapy Designation for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer with KRAS G12 Mutations

Core Insights - Revolution Medicines, Inc. has received Breakthrough Therapy Designation from the FDA for daraxonrasib, a multi-selective inhibitor targeting RAS mutations in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) patients with KRAS G12 mutations [1][3][8] Company Overview - Revolution Medicines is a late-stage clinical oncology company focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes RAS(ON) inhibitors such as daraxonrasib, elironrasib, and zoldonrasib [9] Clinical Development - The Breakthrough Therapy Designation is based on positive results from the Phase 1 RMC-6236-001 clinical trial of daraxonrasib in metastatic PDAC patients [2][8] - The company is currently enrolling patients in the RASolute 302 Phase 3 registrational study, which aims to evaluate daraxonrasib's efficacy in a core population with RAS mutations at position 12 and an expanded population with other RAS mutations [4][8] Market Context - Pancreatic cancer is one of the most lethal cancers, with approximately 60,000 new diagnoses and 50,000 deaths expected in the U.S. in 2024 [5] - PDAC accounts for about 92% of all pancreatic cancer cases, with over 90% of patients having tumors with RAS mutations, highlighting the significant unmet medical need for effective treatments [6][5]