On June 23, 2025, the Food and Drug Administration granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
Full prescribing information for Datroway will be posted on Drugs@FDA.
Efficacy and Safety
Efficacy was evaluated in a pooled subgroup 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 two clinical trials: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (NCT04484142) was a multicenter, single-arm trial, while TROPION-Lung01 (NCT04656652) was a multicenter, open-label, randomized controlled trial.
The major efficacy outcome measures were confirmed overall response rate (ORR) and duration of response (DOR) determined by blinded independent central review per RECIST v1.1. ORR was 45% (95% CI: 35, 54) and median DOR was 6.5 months (95% CI: 4.2, 8.4).
The prescribing information for datopotamab deruxtecan-dlnk includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.
Recommended Dosage
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.
Expedited Programs
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
This application was granted priority review and breakthrough therapy designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
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