Posted by Michael Wonder on 18 Aug 2025
Ifinatamab deruxtecan granted breakthrough therapy designation by US FDA for patients with pre-treated extensive stage small cell lung cancer
18 August 2025 - First breakthrough therapy designation for Daiichi Sankyo and Merck’s ifinatamab deruxtecan based on IDeate-Lung01 phase 2 trial, with support from IDeate-PanTumor01 phase 1/2 trial.
Ifinatamab deruxtecan has been granted breakthrough therapy designation by the US FDA for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
