Officials with the FDA have granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for 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.1
The approval was based, in part, on a pooled subgroup analysis of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC who had received prior treatment with an EGFR-directed therapy and platinum-based chemotherapy, and received datopotamab deruxtecan-dlnk at the recommended dose across 2 clinical trials: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (NCT04484142) was a multicenter, single-arm trial, whereas TROPION-Lung01 (NCT04656652) was a multicenter, open-label, randomized controlled trial.
Overall response rate was 45% (95% CI, 59-80), and median duration of response was 6.5 months (95% CI, 4.2-8.4), according to an FDA statement.
The prescribing information for datopotamab deruxtecan-dlnk includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.
The recommended datopotamab deruxtecan-dlnk dose is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg), as an intravenous infusion once every 3 weeks, until disease progression or unacceptable toxicity.
Reference
- US Food and Drug Administration. FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer. June 23, 2025. Accessed August 14, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-datopotamab-deruxtecan-dlnk-egfr-mutated-non-small-cell-lung-cancer