TRODELVY Gilead Sciences Pty Ltd
Product name
TRODELVY
Sponsor
Accepted date
Apr-2026
Active ingredients
sacituzumab govitecan
Summary of proposed indication
TRODELVY (sacituzumab govitecan) is indicated:
-as first line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed death- receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy.
-in combination with pembrolizumab, as first line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express programmed death-ligand 1(PD-L1) [Combined Positive Score (CPS) ≥ 10].
-as first line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who are not candidates for programmed death- receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy.
-in combination with pembrolizumab, as first line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express programmed death-ligand 1(PD-L1) [Combined Positive Score (CPS) ≥ 10].
Application type
C (new indication)
Publication date
Apr-2026