FDA grants full approval of sacituzumab govitecan-hziy (Trodelvy) for the treatment of previously treated unresectable locally advanced or metastatic triple-negative breast cancer
Full approval granted following data from Phase 3 ASCENT study demonstrated reduction in the risk of disease worsening or death. Progression free disease extended to 4.8 months from 1.7 months with chemotherapy (HR 0.43; 95% CI 0.35-0.54; p<0.0001).
Source:
Biospace Inc.
SPS commentary:
Sacituzumab govitecan-hziy is an antibody-drug conjugate comprising hRS7, a humanised antibody that binds to the trophoblast cell-surface antigen (TROP-2), and SN-38 which is the active metabolite of irinotecan.
Pre-registration has been filed in the EU.