Datopotamab deruxtecan-dlnk is approved by the USFDA 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.

Susan Hau

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Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.

Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.

Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.

Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.

These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.

Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.

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• August 21st, 2025