Table 3 |.

New systemic therapies for metastatic bladder cancer

Drug	Mechanism of action	Evidence	Select adverse events
Erdafitinib	Small-molecule inhibitor of fibroblast growth factor receptor 3	In a phase II study of patients with FGFR3-mutated metastatic urothelial cancer progressing despite prior platinum-based chemotherapy, erdafitinib demonstrated an objective response rate of 42%320	Hyperphosphataemia, stomatitis, hand–foot syndrome as well as ocular disorders such as central serous retinopathy
Enfortumab vedotin	Antibody–drug conjugate comprised of a monoclonal antibody directed against nectin 4 linked to a monomethyl auristatin E payload	The phase III EV-301 trial321 randomized patients with metastatic urothelial cancer progressing despite prior platinum-based chemotherapy and PD1 or PDL1 blockade to treatment with enfortumab vedotin versus standard chemotherapy (docetaxel, paclitaxel or vinflunine); the trial demonstrated an improvement in overall survival with enfortumab vedotin versus chemotherapy (HR 0.70, 95% CI 0.56–0.89; P = 0.001); the combination of enfortumab vedotin plus pembrolizumab has been explored as first-line treatment in cisplatin-ineligible patients with metastatic urothelial cancer322, yielding a 73% response rate	Peripheral neuropathy, hyperglycaemia, rash
Sacituzumab govitecan	Antibody–drug conjugate comprising a monoclonal antibody directed against TROP2 linked to the topoisomerase I inhibitor SN-38 payload	A large phase II trial demonstrated an objective response rate of 27% with sacituzumab govitecan in patients with metastatic urothelial cancer progressing despite prior platinum-based chemotherapy and PD1 or PDL1 immune-checkpoint inhibition323	Diarrhoea, neutropenia

New systemic therapies that have received regulatory approval in at least one region of the world are shown.