Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 180 mg lyophilized powder in single-dose vials) |
| Drug Class | Trop-2-directed antibodies and topoisomerase inhibitor conjugates |
| 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 endocrine-based 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 (PD-L1) inhibitor.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Metastatic Urothelial Carcinoma: Sacituzumab govitecan (Trodelvy) demonstrated an objective response rate (ORR) ranging from 27% to 52% as monotherapy, and 34% to 75% when combined with anti-PD-1 agents. It has shown efficacy similar to other antibody-drug conjugates (ADCs) like enfortumab vedotin, which is approved for first-line treatment in combination with pembrolizumab.
- Metastatic Triple-Negative Breast Cancer (mTNBC): Sacituzumab govitecan outperformed other treatments in second and subsequent lines of treatment, including progression-free survival (PFS) and overall survival (OS) endpoints. It was superior to treatments like PARP (poly (ADP-ribose) polymerase) inhibitors (talazoparib, olaparib) and chemotherapy agents (nab-paclitaxel, capecitabine, eribulin) in ORR, PFS, and OS.
- Guideline Recommendations: Sacituzumab govitecan is recommended as a third-line treatment for patients with mTNBC who have already undergone at least two prior therapies.
- The studies indicate that antibody-drug conjugates (ADCs) like sacituzumab govitecan are designed to reduce systemic toxicities compared to conventional chemotherapy. However, specific adverse effects of sacituzumab govitecan are not provided.
- In mTNBC, platinum-based polychemotherapies were noted to have higher toxicity compared to other treatments, but detailed safety outcomes for sacituzumab govitecan are not specified.
- The population types and subgroups in the provided evidence focus on patients with metastatic urothelial carcinoma and mTNBC. Specific subgroups include those with programmed cell death ligand 1 (PD-L1)-positive vs. PD-L1-negative mTNBC, and patients with germline breast cancer gene (BRCA) mutations, where sacituzumab govitecan demonstrated superior outcomes in later treatment lines, especially in PD-L1-positive and germline BRCA mutation-positive mTNBC.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Trodelvy (sacituzumab govitecan-hziy) Prescribing Information. | 2024 | Gilead Sciences Inc., Foster City, CA, USA |