Merck's ADC Candidate I-DXd Receives FDA Breakthrough Therapy Designation for Lung Cancer Treatment

Merck's ADC candidate, ifinatamab deruxtecan, has received Breakthrough Therapy designation from the FDA for treating adult patients with extensive-stage small cell lung cancer. The decision was based on data from the phase II IDeate-Lung01 study and phase I/II IDeate-PanTumor01 study. The ADC is being developed in partnership with Daiichi Sankyo, which markets Enhertu, a HER2-directed ADC.