# 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

### Triple-negative breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| PD-L1 CPS ≥ 10 | + pembrolizumab | 1st line, advanced | No prior systemic therapy for metastatic disease |
| None | Monotherapy | 1st line, advanced | No prior systemic therapy for metastatic disease; Not candidates for PD-1 or PD-L1 inhibitor therapy |
| None | Monotherapy | 2nd line, advanced | After two or more prior systemic therapies, including at least one of them for advanced disease |

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | Monotherapy | 3rd line+, advanced | After endocrine-based therapy, and at least two additional systemic therapies in the advanced setting |

## Products

### Trodelvy

- Company: Gilead Sciences Ireland UC
- Target: TROP2-directed antibody-drug conjugate
- Class: Other monoclonal antibodies and antibody drug conjugates
- ATC: L01FX06
- EU approval: 22 Nov 2021
- Label revised: 15 Sep 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/trodelvy-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy

Mechanism (SmPC section 5.1): Binds Trop-2-expressing tumour cells and internalises to release SN-38, which inhibits topoisomerase I, causing DNA damage and cell death.

## Label wording

- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 1st line, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Triple-negative breast cancer, 2nd line, advanced: “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)” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)
- **Sacituzumab govitecan** (Trodelvy), Breast cancer, 3rd line+, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/trodelvy-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/sacituzumab-govitecan