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FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer
On June 23, 2025, the Food and Drug Administration conferred 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 previously undergone EGFR-targeted therapy and platinum-based chemotherapy.
Safety and Efficacy
The efficacy was assessed in a combined subgroup of 114 patients with locally advanced or metastatic EGFR-mutated NSCLC, who had previously undergone treatment with an EGFR-targeted therapy and platinum-based chemotherapy, and who received datopotamab deruxtecan-dlnk at the recommended dosage in two clinical trials: TROPION-Lung05 and TROPION-Lung01. TROPION-Lung05 (NCT04484142) was a multicenter, single-arm study, whereas TROPION-Lung01 (NCT04656652) was a multicenter, open-label, randomized controlled trial.
The primary efficacy outcome measures were the overall response rate (ORR) and duration of response (DOR), assessed by blinded independent central review according to RECIST v1.1. The overall response rate (ORR) was 45% (95% confidence interval: 35, 54), and the median duration of response (DOR) was 6.5 months (95% confidence interval: 4.2, 8.4).
The prescribing information for datopotamab deruxtecan-dlnk contains warnings and precautions regarding interstitial lung disease/pneumonitis, eye side reactions, stomatitis, and embryo-fetal damage.
Suggested Dosage
The advised dosage of datopotamab deruxtecan-dlnk is 6 mg/kg (capped at 540 mg for patients weighing > 90 kg), administered as an intravenous infusion every three weeks, until disease progression or intolerable toxicity occurs.
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About Sai Sree
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Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
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