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[FDA Accelerated Approval] Datroway by Daiichi Sankyo approved for EGFR-mutated non-small cell lung cancer (June 23, 2025)
On June 23, 2025, the U.S. FDA granted accelerated approval to Datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-targeted therapy and platinum-based chemotherapy.
Disease Background and Significance
EGFR-mutated NSCLC is initially treated with EGFR inhibitors, but resistance often develops. Datroway, an antibody-drug conjugate (ADC), offers a new therapeutic option for patients with progression after standard therapies.
Therapy Summary
- Drug: Datopotamab deruxtecan-dlnk (Datroway)
- Company: Daiichi Sankyo
- Approval Date: June 23, 2025 (Accelerated)
- Indication: Locally advanced/metastatic EGFR-mutated NSCLC post-EGFR and platinum therapy
- Dosing: 6 mg/kg (up to 540 mg), IV infusion every 3 weeks
- Key Trials: TROPION-Lung05 (single-arm) and TROPION-Lung01 (RCT)
- Key Results: ORR 45% (95% CI: 35–54), median duration of response: 6.5 months (95% CI: 4.2–8.4)
Safety and Warnings
- Interstitial lung disease/pneumonitis
- Ocular toxicity, stomatitis, embryo-fetal toxicity
Commentary
Datroway’s approval marks an important advancement in treatment sequencing for advanced EGFR-mutated NSCLC. The ADC strategy continues to show promise in post-TKI settings.
Source
Data from the U.S. FDA: Drugs@FDA
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