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MAY 22 2026
APPROVED · 130 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

Triple-negative breast cancer is an aggressive form of the disease that lacks the three most common receptors, limiting standard treatment options. Datroway is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells by targeting the TROP2 protein on their surface. This targeted delivery could potentially attack tumors more precisely while sparing healthy tissue.

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