On June 23, 2025, the US Food and Drug Administration (FDA) announced the approval of datopotamab deruxtecan-dlnk (Datroway® or Dato-DXd) to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the EGFR (epidermal growth factor receptor) gene. This approval is for patients who have been previously treated with an EGFR-directed therapy and chemotherapy.
This ADC, or antibody-drug conjugate, is designed with two key elements.
- One part of the treatment binds specifically to the TROP-2 protein on the surface of cancer cells.
- The other part of the treatment carries an important payload—a drug that specifically targets and kills the cell.
The FDA approval is supported by data pooled from two clinical trials: TROPION-Lung05 and TROPION-Lung01. The trials showed that of 114 patients, 45% had their tumors shrink or disappear with this treatment (overall response rate), and this response to treatment lasted approximately 6.5 months (median duration of response).
It’s important to note that this is an accelerated approval intended to bring treatments to patients as quickly as possible. This drug continues to be tested in clinical trials.
For more information, please see the FDA’s press release.