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.
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.