Ifinatamab deruxtecan granted Breakthrough Therapy Designation by U.S. FDA for patients with pretreated extensive stage small cell lung cancer

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18 August 2025: Ifinatamab deruxtecan granted Breakthrough Therapy Designation by U.S. FDA for patients with pretreated extensive stage small cell lung cancer

The U.S. FDA has granted Breakthrough Therapy Designation (BTD) to ifinatamab deruxtecan (I-DXd) for adult patients with extensive-stage small cell lung cancer who progressed after platinum-based chemotherapy
Ifinatamab deruxtecan is a potential first-in-class B7-H3 directed DXd antibody-drug conjugate developed by Daiichi Sankyo and Merck
The designation is based on positive data from the Phase 2 IDeate-Lung01 trial, supported by the Phase 1/2 IDeate-PanTumor01 trial
This is the first BTD for Ifinatamab deruxtecan and the fourteenth across Daiichi Sankyo’s oncology portfolio
Results from IDeate-Lung01 will be presented at the IASLC 2025 World Conference on Lung Cancer, highlighting its potential to address significant unmet medical needs in this aggressive disease