Merck’s Calderasib Receives FDA Breakthrough Therapy Designation for Lung Cancer
Merck has secured a significant regulatory milestone for its investigational cancer therapy, calderasib (MK-1084), after the U.S. Food and Drug Administration (FDA) granted the treatment Breakthrough Therapy designation.
The recognition applies to calderasib when used alongside pembrolizumab as an initial treatment option for patients diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) carrying the KRAS G12C genetic alteration and PD-L1-positive tumours.
The FDA's decision follows encouraging early-stage clinical findings that suggest the combination may offer meaningful clinical benefit for a group of patients with limited targeted treatment options.
KRAS G12C is a cancer-driving mutation found in a notable proportion of NSCLC cases and has become an important focus of drug development efforts.
By granting Breakthrough Therapy designation, the FDA aims to support the faster development and assessment of therapies that show promise in addressing serious diseases.
