Ifinatamab deruxtecan is a potentially first-in-class antibody-drug conjugate (ADC) targeting B7-H3, designed using proprietary technology. It is developed by Daiichi Sankyo (TSE: 4568) and co-developed with Merck.

The FDA Breakthrough Therapy designation aims to expedite the development and regulatory review of drugs for serious diseases that address significant unmet medical needs. Drugs granted this designation must show promising efficacy in early clinical studies, demonstrating substantial improvement over existing treatments on clinically meaningful study endpoints.

This FDA Breakthrough Therapy designation is based on data from the IDeate-Lung01 Phase II trial, supported by data from the IDeate-PanTumor01 Phase I/II trial. The primary analysis results of the IDeate-Lung01 study will be presented as the latest key oral report at the 2025 World Conference on Lung Cancer (#WCLC25), organized by the International Association for the Study of Lung Cancer. This is the first BTD received by ifinatamab deruxtecan and the first BTD obtained since the collaboration between Daiichi Sankyo and Merck began.