Global InformationSacituzumab govitecan information
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| Monoclonal antibody | |
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| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | Trop-2 |
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| Trade names | Trodelvy |
| Other names | IMMU-132, hRS7-SN-38, sacituzumab govitecan-hziy |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a620034 |
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| Routes of administration | Intravenous |
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| Formula | C76H104N12O24S |
| Molar mass | 1601.79 g·mol−1 |
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Sacituzumab govitecan, sold under the brand name Trodelvy by Gilead Sciences, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.[9][11][12][13]
The most common side effects include nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia (hair loss), constipation, decreased appetite, rash and abdominal pain.[12][13][14] Sacituzumab govitecan has a boxed warning about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea.[12][13] Sacituzumab govitecan may cause harm to a developing fetus or newborn baby.[12]
Sacituzumab govitecan was approved for medical use in the United States in April 2020,[12][13][15] and in the European Union in November 2021.[10] The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider it to be a first-in-class medication.[16][17]
- ^ a b "Trodelvy". Therapeutic Goods Administration (TGA). 14 September 2021. Archived from the original on 17 September 2021. Retrieved 17 September 2021.
- ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
- ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
- ^ "Trodelvy sacituzumab govitecan 180 mg powder for injection vial". Therapeutic Goods Administration (TGA). Archived from the original on 17 September 2021. Retrieved 17 September 2021.
- ^ "TGA eBS - Product and Consumer Medicine Information Licence". Archived from the original on 22 February 2022. Retrieved 22 February 2022.
- ^ "AusPAR: Sacituzumab govitecan | Therapeutic Goods Administration (TGA)". Archived from the original on 24 November 2022. Retrieved 24 November 2022.
- ^ "Trodelvy | Therapeutic Goods Administration (TGA)". Archived from the original on 24 November 2022. Retrieved 24 November 2022.
- ^ "Summary Basis of Decision (SBD) for Trodelvy". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
- ^ a b "Trodelvy- sacituzumab govitecan powder, for solution". DailyMed. Archived from the original on 20 March 2021. Retrieved 9 April 2021.
- ^ a b "Trodelvy EPAR". European Medicines Agency. 14 September 2021. Archived from the original on 25 November 2021. Retrieved 24 November 2021.
- ^ Cite error: The named reference
FDA sacituzumab govitecan-hziywas invoked but never defined (see the help page). - ^ a b c d e "FDA Approves New Therapy for Triple Negative Breast Cancer That Has Spread, Not Responded to Other Treatments". U.S. Food and Drug Administration (FDA). 22 April 2020. Archived from the original on 23 April 2020. Retrieved 22 April 2020.
This article incorporates text from this source, which is in the public domain.
- ^ a b c d Cite error: The named reference
FDA snapshotwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FDA 20210408was invoked but never defined (see the help page). - ^ "Drug Approval Package: Trodelvy". U.S. Food and Drug Administration (FDA). 19 May 2020. Archived from the original on 20 October 2021. Retrieved 10 February 2023.
- ^ "New Drug Therapy Approvals 2020". U.S. Food and Drug Administration (FDA). 31 December 2020. Archived from the original on 18 January 2021. Retrieved 17 January 2021. This article incorporates text from this source, which is in the public domain.
- ^ "First-in-class medicine to treat aggressive form of breast cancer". European Medicines Agency (Press release). 15 October 2021. Archived from the original on 15 October 2021. Retrieved 15 October 2021.
