Sacituzumab govitecan

Sacituzumab govitecan (Trodelvy, Gilead Sciences Ireland UC) has 4 EU-approved indications in 2 tumour types. 2 need a biomarker result: Hormone receptor (1) and PD-L1 (1).
Approved indications of Sacituzumab govitecan
Biomarker requirementRegimenSettingConditions
Triple-negative breast cancer3
PD-L1 CPS ≥ 10
+ pembrolizumab
1L
advanced
No prior systemic therapy for metastatic disease
None
Monotherapy
1L
advanced
No prior systemic therapy for metastatic disease; Not candidates for PD-1 or PD-L1 inhibitor therapy
None
Monotherapy
2L
advanced
After two or more prior systemic therapies, including at least one of them for advanced disease
Breast cancer1
Hormone receptor-positive, HER2-negative
Monotherapy
3L+
advanced
After endocrine-based therapy, and at least two additional systemic therapies in the advanced setting
Full text of section 4.1 (therapeutic indications)

Triple-Negative Breast Cancer Trodelvy is indicated: • in combination with pembrolizumab, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see sections 4.2 and 5.1). • as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). • as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting (see section 5.1).

Label history

8 changes to the Trodelvy label since 2023, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes