Datroway first US-approved TROP2-directed therapy in lung cancer

24 June 2025

The US Food and Drug Administration (FDA) has approved Datroway (datopotamab deruxtecan or Dato-DXd) to treat adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

This indication is approved under accelerated approval, based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

We remain committed to our extensive clinical development program to further identify where Datroway may be used in other types of lung and breast cancer

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