Datroway® (datopotamab deruxtecan-dlnk)

BL 761394 [BL 761464]

Datroway® (datopotamab deruxtecan-dlnk)

BL 761394 [BL 761464]

U.S. License Holder:

Daiichi Sankyo Inc.

Date of License:

January-17-2025 [June-23-2025]

Last Update:

July-15-2025

approved_indications FDA-Approved Indications

BL 761394: DATROWAY (datopotamab deruxtecan-dlnk) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

BL 761464: DATROWAY (datopotamab deruxtecan-dlnk) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of:

Adult patients 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;

Adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Methodology

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