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.
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.