FDA Grants Accelerated Approval to Datopotamab Deruxtecan‑DLNK (Datroway) for EGFR-Mutated NSCLC

On June 23, 2025, the U.S. Food and Drug Administration granted accelerated approval to datopotamab deruxtecan‑DLNK (Datroway; Daiichi Sankyo, Inc.) for the treatment of adults with locally advanced or metastatic EGFR-mutated non‑small cell lung cancer (NSCLC) who have received prior EGFR-targeted therapy and platinum-based chemotherapy

The efficacy evaluation was based on pooled data from 114 patients within the TROPION‑Lung05 (phase 2, single-arm) and TROPION‑Lung01 (phase 3, open-label, randomized) trials. Treatment was administered at the recommended dose of 6 mg/kg intravenously every 3 weeks (up to 540 mg in heavier patients). The confirmed overall response rate (ORR) reached 45% (95% CI: 35–54%), and the median duration of response (DOR) was 6.5 months (95% CI: 4.2–8.4 months).

Prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo‑fetal toxicity.

Administration should continue until disease progression or unacceptable toxicity occurs, consistent with the accelerated-approval framework.

Datroway represents the first Trop‑2‑directed antibody‑drug conjugate (ADC) to receive FDA approval in this treatment setting, marking a significant therapeutic advancement. Continued approval will depend on verification of clinical benefit in post‑approval confirmatory trials.

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