Posted by Michael Wonder on 13 Apr 2021
FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer
13 April 2021 - Today the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients with locally advanced or metastatic urothelial cancer 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, a single-arm, multi-center trial that enrolled 112 patients with locally advanced or mUC who received prior treatment with a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.
