FDA Grants Breakthrough Therapy Designation to Calderasib for KRAS G12C-Mutant Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to calderasib (MK-1084), an investigational KRAS G12C inhibitor, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1. This designation is based on positive data from the Phase 1 KANDLELIT-001 trial. Calderasib, developed by Merck, is a next-generation KRAS G12C covalent inhibitor, targeting a mutation found in approximately 14% of NSCLC patients. The FDA's Breakthrough Therapy designation aims to expedite the development and review of drugs that show substantial improvement over existing therapies for serious conditions. 
