Sacituzumab govitecan, sold under the brand name Trodelvy, 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.The most common side effects include nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia (hair loss), constipation, decreased appetite, rash and abdominal pain. Sacituzumab govitecan has a boxed warning about the risk of severe neutropenia (abnormally low levels of white blood cells) and severe diarrhea. Sacituzumab govitecan may cause harm to a developing fetus or newborn baby. Women are advised not to breastfeed while on sacituzumab govitecan and one month after the last dose is administered.The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) consider it to be a first-in-class medication. Sacituzumab govitecan was approved for medical use in the European Union in November 2021. Medical uses
Sacituzumab govitecan is indicated for the treatment of adults with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease; people 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; and for people with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Administration
Sacituzumab govitecan is given in a 21-day treatment cycle in which an injection is only given a few days of the cycle.
Participants were randomized (1:1) to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, on days 1 and 8 of a 21-day (n=267) cycle or physicians choice of single agent chemotherapy (n=262).In April 2021, the FDA granted accelerated approval to sacituzumab govitecan for people with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY (IMMU-132-06; NCT03547973), a single-arm, multicenter trial that enrolled 112 participants with locally advanced or mUC who received prior treatment with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Society and culture
Legal status
On 14 October 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Trodelvy, intended for the treatment of unresectable or metastatic triple-negative breast cancer. The applicant for this medicinal product is Gilead Sciences Ireland UC. Sacituzumab govitecan was approved for medical use in the European Union in November 2021. References
Further reading
Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR,  et al. (February 2019). "Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer". N. Engl. J. Med. 380 (8): 741–751. doi:10.1056/NEJMoa1814213. PMID 30786188. Weiss J, Glode A, Messersmith WA, Diamond J (August 2019). "Sacituzumab govitecan: breakthrough targeted therapy for triple-negative breast cancer". Expert Rev Anticancer Ther. 19 (8): 673–79. doi:10.1080/14737140.2019.1654378. PMID 31398063. S2CID 199518147. External links
"Sacituzumab govitecan". Drug Information Portal.