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On February 2023, the FDA approved the medicine Trodelvy (sacituzumab govitecan-hziy) for the treatment of unresectable locally advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Trodelvy comes in the form of 180 mg lyophilized powder in single-dose vials for reconstitution. Trodelvy  180 mg is a Trop-2-directed antibody and topoisomerase inhibitor conjugate composed of the following three components:

  • The humanized monoclonal antibody, hRS7 IgG1κ (also called sacituzumab), which binds to Trop-2 (the trophoblast cell-surface antigen-2);
  • The drug SN-38, a topoisomerase inhibitor;
  • A hydrolysable linker (called CL2A), which links the humanized monoclonal antibody to SN-38.

The primary efficacy outcome measure was progression-free survival determined by an anonymous independent central review per RECIST v1.1. A key secondary efficacy outcome measure was overall survival. Median progression-free survival was 5.5 months in the sacituzumab govitecan-hziy arm and 4 months in the single-agent chemotherapy arm. Median overall survival was 14.4 months for those receiving sacituzumab govitecan-hziy and 11.2 months for those receiving single-agent chemotherapy.

The common side effects of sacituzumab govitecan-hziy are decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, increased glucose, constipation, and decreased albumin.


Nitin Goswami

Nitin Goswami joined us as an Editor in 2020. He covers all the updates in the field of Pharmaceutical, Business Healthcare, Health News, Medical News, and Pharma News.

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