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MAY 22 2026
APPROVED · 12 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 breast cancer that lacks three common hormone receptors, making it harder to treat with standard therapies. Datroway is an antibody-drug conjugate that targets the TROP2 protein on cancer cells, delivering a potent chemotherapy agent directly to the tumor. By focusing treatment on cancer cells while sparing healthy tissue, Datroway may offer a more effective option for patients with advanced triple-negative breast cancer.

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