Aug. 25, 2025—Ifinatamab deruxtecan (I-DXd) has been granted breakthrough therapy designation by the FDA for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate being jointly developed by Daiichi Sankyo and Merck. The FDA granted the breakthrough therapy designation based on data from the IDeate-Lung01 phase two trial, with support from the IDeate-PanTumor01 phase one/two trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (Barcelona, Spain, Sept. 6–9).