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. 2015 Mar 26;6(11):8454–8473. doi: 10.18632/oncotarget.3502

Table 1. FDA-approved and investigational therapies for urothelial carcinoma.

Drug category Drug urothelial carcinoma FDA approved or clinical trial phase Type / stage of cancer
Chemotherapy Cisplatin (alkylating agent) Approved T4b and metastatic urothelial carcinoma
Doxorubicin hydrochloride (topoisomerase II inhibitor) Approved Stage IV and recurrent bladder cancer
Gemcitabine hydrochloride Approved Advanced bladder cancer
5-fluoro-2′-deoxcytidine + tetrahydrouridine Phase II Advanced bladder cancer
Eribulin mesylate (E7389) Phase I / II Locally advanced or metastatic bladder cancer
Veliparib / ABT-888 Phase I Non-resectable or metastatic
Romidepsin (histone deacetylase inhibition) Phase I Advanced urothelial carcinoma
Anti-tumor immunity rhIL-7 vaccine Phase II Metastatic urothelial carcinoma
DC205-NY-ESO-1 fusion protein vaccine +/− sirolimus Phase I Metastatic urothelial carcinoma
Ad/HER2/Neu dendritic cell vaccine Phase I T3a and above HER2+ bladder cancer
Bacillus Calmette-Guerin + PANVAC Phase II Non-muscle invasive bladder cancer
ALT-801 (IL-2 recombinant fusion protein) post-chemotherapy with cisplatin and gemcitabine Phase I / II Advanced stage muscle-invasive bladder cancer
mTOR inhibitors ABI-009 (nab-rapamycin) Phase I / II Advanced non-muscle invasive bladder cancer
Sirolimus, post-chemotherapy with cisplatin and gemcitabine hydrochloride Phase I / II T2 to T4 tumors
Anti-angiogenic therapy Cabozantinib Phase II Advanced stage bladder cancer
Bevacizumab, post-chemotherapy with gemcitabine hydrochloride + cisplatin Phase III Metastatic, unresectable, or locally advanced bladder cancer
Lenalidomide, post-chemotherapy with gemcitabine hydrochloride and carboplatin Phase I Unresectable or metastatic bladder cancer
Tyrosine kinase inhibitors Afatinib Phase II Ureteral cancer, stage III, stage IV urothelial carcinoma
Dovitinib Phase II BCG-refactory urothelial carcinoma, FGFR3-mutated urothelial carcinoma
Erlotinib Phase II Stage I, II, III and recurrent urothelial carcinoma
Gefitinib Phase II (completed) Locally advanced and metastatic bladder cancer
Pazopanib Phase II (completed) Locally advanced and metastatic bladder cancer
Sorafenib Phase II (completed) Locally advanced and metastatic bladder cancer
Sunitinib Phase II BCG-refactory bladder cancer
HER2 blockade Afatinib (targets EGF and HER2) Phase II Refactory bladder cancer
MGAH22, a human chimeric antibody against HER2 Phase I HER2 positive bladder cancer