What Dato-DXd is
Datopotamab deruxtecan (“Dato-DXd”) is an antibody–drug conjugate (ADC). It uses an antibody that locks onto the TROP-2 protein on many lung-cancer cells and then delivers a potent chemotherapy payload directly inside the tumor. Think of it as a guided “smart bomb” designed to spare more of your healthy tissue.
Where regulatory approval stands today
Dato-DXd is not yet approved for lung cancer. The FDA accepted the Biologics Licence Application in January 2025 and granted Priority Review for people with EGFR-mutated, advanced non-small-cell lung cancer (NSCLC) who have already had EGFR-targeted therapy and chemotherapy. A final decision is expected later in 2025
What to Expect from Dato-DXd in Lung Cancer
This document summarizes key clinical trial findings for Dato-DXd in non-small cell lung cancer (NSCLC), focusing on results from two studies: the Phase II TROPION-Lung05 and the Phase III TROPION-Lung01 trials. Special attention is given to the outcomes in patients with EGFR-mutated, including a deeper analysis of Dato-DXd’s potential role in this molecular subgroup.
