Sacituzumab govitecan-hziy

(Trodelvy®)

Sacituzumab govitecan-hziy

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 180 mg lyophilized powder in single-dose vial)
Drug ClassTrop-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
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  • 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.