Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous: 180 mg lyophilized powder in single-dose vial) |
| Drug Class | Trop-2-directed antibody and topoisomerase inhibitor conjugates |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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
- 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 (Trodelvy) is used for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer, and locally advanced or metastatic urothelial cancer.
- Two systematic reviews/meta-analyses were reviewed to gather information about sacituzumab govitecan's efficacy and safety profile in treating these conditions.
- The first review found that sacituzumab govitecan showed a complete response rate of 4.9%, partial response rate of 35.6%, objective response rate of 6.8% among relapsed/refractory mTNBC patients; however, it was associated with adverse events such as neutropenia, fatigue, anemia and nausea.
- In comparison to chemotherapy alone in HER-2 positive BC cases from four randomized clinical trials included in the second meta-analysis study, antibody-drug conjugates like Trodelvy improved progression-free survival (PFS) and overall survival rates significantly.
- For triple negative BC cases treated with saci-gov versus chemotherapy according to one RCT included in the same analysis report mentioned above, hazard ratios for PFS and OS were notably lower indicating better outcomes using this drug compared to standard therapy options.
- The common grade ≥3 adverse events reported across studies include anemia, rash, fatigue, hypertension, and elevated aminotransferases.
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
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 |