EMA: adequate pharmacodynamic data; ADC inhibits Trop-2-positive tumour growth in vitro and in mouse xenografts
“The applicant has presented adequate non-clinical data which characterise the pharmacodynamic properties of sacituzumab govitecan. These data were presented in research study reports and in form of publications from the group in scientific journals. The ADC inhibits growth of Trop-2-positive tumour cells, including TNBC cells, in vitro as well as in xenograft transplant models in mice.”