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 Cancer (NSCLC)

RAHWAY, N.J.--(BUSINESS WIRE)---- $MRK #MRK--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), Merck's anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and e.