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Review

Sacituzumab Govitecan

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Sacituzumab Govitecan

No authors listed.
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Excerpt

Sacituzumab govitecan is a humanized monoclonal antibody conjugate which is used in the therapy of refractory, locally advanced or metastatic breast and urothelial cancer. Sacituzumab govitecan has been linked to transient mild-to-moderate serum enzyme elevations during therapy but has not been implicated in cases of liver injury with jaundice.

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References

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    1. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761115Orig1s000M...(FDA website with product labels and initial multidiscipline review of sacituzumab govitecan mentions that the most common side effects were diarrhea and neutropenia and that ALT elevations above 5 times ULN in 1.5% of patients in the safety population of 408 exposed patients; no discussion of serious hepatoxicity).
    1. Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, et al. Efficacy and safety of anti-trop-2 antibody drug conjugate sacituzumab govitecan (IMMU-132) in heavily pretreated patients with metastatic triple-negative breast cancer. J Clin Oncol. 2017;35:2141-2148.(Among 69 adults with refractory or relapsed, metastatic triple-negative breast cancer treated with sacituzumab govitecan, the objective response rate was 30%, all responders having moderate to strong Trop-2 expression in cancer cells; side effects were not listed except for severe diarrhea [24%] and febrile neutropenia [7%]). - PMC - PubMed
    1. Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, O'Shaughnessy J, et al. Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer. N Engl J Med. 2019;380:741-751.(Among 108 adults with refractory metastatic triple negative breast cancer treated with sacituzumab govitecan, the objective response rate was 33% and overall survival 13 months, while the most common adverse events were nausea, diarrhea, fatigue, neutropenia, and anemia, and serious adverse events occurred in 32% leading to dose adjustments in 44%, discontinuations in 3%, and death in 4% of treated patients; ALT elevations occurred in 14% and were above 5 times ULN in 1% ). - PubMed
    1. Joubert N, Beck A, Dumontet C, Denevault-Sabourin C. Antibody-drug conjugates: the last decade. Pharmaceuticals (Basel). 2020;13:245.(Review of the development, structure, efficacy, adverse event rates and approval of vector-based chemotherapy using selective delivery by a monoclonal antibody and cancer cell injury by a conjugated cellular toxin [payload] including nine that are FDA approved and six others in pivotal trials). - PMC - PubMed

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