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MAY 22 2026
APPROVED · 70 DAYS AGO

Daiichi Sankyo Datroway (datopotamab deruxtecan-dlnk)

for unresectable or metastatic triple-negative breast cancer

BLA

FDA approved Datroway for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

About

Datopotamab deruxtecan is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells by targeting the TROP2 protein on their surface. This approach aims to concentrate the cell-killing drug at the tumor while limiting exposure to healthy tissues. For patients with this aggressive form of breast cancer, it may offer a new treatment option when other specific therapies are not suitable.

Pivotal trial

MICA Phase 1 active not recruiting NCT05117476

CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Source: ClinicalTrials.gov