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.
Mantleoma is a benign neoplasm with mantle differentiation and they tend to occur on the face, early neoplasms consist only of cords and columns of undifferentiated epithelial cells. : 675

See also
Trichodiscoma
Fibrofolliculoma


== References ==