FDA Approves Datopotamab Deruxtecan for Patients With EGFR-Mutated Non-Small Cell Lung Cancer
On June 23, 2025, the US Food and Drug Administration (FDA) approved datopotamab deruxtecan for previously treated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). This approval was based on pooled subgroup results from the TROPION-Lung 05 and TROPION-Lung 01 trials.
In these studies, 114 patients who previously received an EGFR-directed therapy and platinum-based chemotherapy received 6 mg/kg (or up to 540 mg maximum for patients ≥ 90 kg) of intravenous datopotamab deruxtecan once every 3 weeks until disease progression or unacceptable toxicity. Primary end points included confirmed overall response rate (ORR) and duration of response, assessed via blinded independent central review. A key secondary end point was safety.
At analysis, the ORR was 45% and the median duration of response was 6.5 months. The most frequently observed adverse events included interstitial lung disease, pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.
The recommended dose of datopotamab deruxtecan is 6 mg/kg (or up to 540 mg maximum for patients ≥ 90 kg) administered intravenously once every 3 weeks until disease progression or unacceptable toxicity.
Source:
FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer. Accessed on June 23, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer
