FDA grants breakthrough therapy designation to Merck's KRAS G12C inhibitor
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FDA Grants Breakthrough Therapy Designation for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients with Newly Diagnosed Metastatic KRAS G12C-Mutant Non-Small Cell Lung
May 29, 2026 6:45 AM EDTFirst Breakthrough Therapy designation for calderasib, supported by positive data from the Phase 1 KANDLELIT-001 trial
Calderasib is an investigational, highly potent and specific next-generation KRAS G12C covalent inhibitor
RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA® (pembrolizumab), Mercks anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug... More
