U.S. License Holder:
Immunomedics Inc.
Date of License:
April-22-2020
Last Update:
June-30-2026
FDA-Approved Indications
TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated:
Locally Advanced or Metastatic Breast Cancer:
First Line:
As a single agent for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy;
In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adult patients with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS greater than or equal to 10) as determined by an FDA-authorized test;
Second Line or Later: For the treatment of adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease;
Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer: For the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
