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)
First 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
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 expressing PD-L1 (tumor proportion score [TPS] ≥1%). This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial.
“As our understanding of cancer biology and precision medicine continues to advance, we’re encouraged by the potential of new approaches, like calderasib, to help address the underlying drivers of cancer growth,” said Dr. Shweta Jain, vice president, global clinical development, Merck Research Laboratories. “The Breakthrough Therapy designation for calderasib underscores the promising potential of this medicine and unmet need for certain patients with KRAS G12C-mutated NSCLC.”
