FDA grants accelerated approval to datopotamab deruxtecan-dlnk for EGFR-mutated non-small cell lung cancer
Regulatory approval: On June 23, 2025, the FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway) for adults with locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and platinum-based chemotherapy. Approval was supported by a pooled subgroup (n=114) from TROPION-Lung05 and TROPION-Lung01, with confirmed ORR 45% (95% CI 35–54) and median DOR 6.5 months (95% CI 4.2–8.4). Key warnings include ILD/pneumonitis and ocular AEs.
FDA accelerated approval (June 23, 2025)
The FDA granted accelerated approval on June 23, 2025 to datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo, Inc.) 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.
Supporting evidence
Efficacy was evaluated in a pooled subgroup of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC treated at the recommended dose across two trials:
- TROPION-Lung05 (NCT04484142): multicenter, single-arm trial
- TROPION-Lung01 (NCT04656652): multicenter, open-label, randomized controlled trial
Major efficacy endpoints were confirmed overall response rate (ORR) and duration of response (DOR) by blinded independent central review per RECIST v1.1. Reported outcomes were:
- ORR: 45% (95% CI, 35–54)
- Median DOR: 6.5 months (95% CI, 4.2–8.4)
Safety and dosing (label highlights)
Prescribing information includes warnings/precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.
Recommended dosage: 6 mg/kg IV every 3 weeks (maximum 540 mg for patients ≥90 kg) until disease progression or unacceptable toxicity.
The application received priority review and breakthrough therapy designation.