Drug updated on 5/17/2024
| Dosage Form | Injection (intravenous; 180 mg lyophilized powder in single-dose vial) |
| Drug Class | Trop-2-directed antibody and topoisomerase inhibitor conjugate |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- Indicated 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 endocrinebased therapy and at least two additional systemic therapies in the metastatic setting.
- Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PDL1) inhibitor.
Summary
- Sacituzumab govitecan-hziy (Trodelvy) is indicated for the treatment of adult patients with various types of unresectable locally advanced or metastatic cancers, including triple-negative breast cancer (mTNBC), hormone receptor-positive and human epidermal growth factor receptor 2-negative breast cancer, and urothelial cancer. The drug has shown effectiveness in cases where patients have received two or more prior systemic therapies.
- Four systematic reviews/meta-analyses were reviewed to gather information about Trodelvy's safety and efficacy. These studies provided a comprehensive overview of the drug's performance across different patient populations and compared it to other treatments.
- In terms of effectiveness, sacituzumab govitecan-hziy demonstrated superior outcomes in progression-free survival and overall survival compared to standard care in third-line treatment settings for mTNBC. It also showed high objective response rates that outperform typical treatments.
- Safety concerns associated with sacituzumab govitecan-hziy primarily revolve around hematologic adverse events such as neutropenia and leukopenia. However, these side effects are considered manageable given the significant benefits offered by this potent anticancer treatment.
- Sacituzumab govitecan-hziy was found effective across a broad range of patient subgroups including those positive for hormone receptors, triple-negative status, HER2-low status as well as BRCA1/2 mutations or PD-L1 positivity indicating its versatility within varying lines of therapy.
- Overall findings suggest that sacituzumab govitecan-hziy offers meaningful advancements in managing difficult-to-treat metastatic cancers especially when first- and second-line treatments have failed, making it an important option to consider.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Trodelvy (sacituzumab govitecan-hziy) Prescribing Information. | 2022 | Gilead Sciences, Inc., Morris Plains, NJ, USA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Sacituzumab govitecan as a second-line treatment in relapsed/refractory metastatic triple-negative breast cancer patients: a systematic review and meta-analysis. | 2024 | The Annals of Pharmacotherapy |
| Third-line treatment for metastatic triple-negative breast cancer: a systematic review and network meta-analysis. | 2024 | American Journal of Clinical Oncology |
| Efficacy and safety of antibody-drug conjugates in triple-negative and HER-2 positive breast cancer: a systematic review and meta-analysis of clinical trials. | 2023 | Breast Disease |
| Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancer. | 2022 | Cancer Treatment Reviews |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Chemotherapy and targeted therapy for patients with human epidermal growth factor receptor 2–negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor–negative: ASCO guideline update. | 2021 | Journal of Clinical Oncology |