Table 1.
FDA approval timeline for novel UC therapies from 2015 to 2021.
| Name of Drug | Class | FDA Approval Date | Studies Supporting Approval |
|---|---|---|---|
| Atezolizumab | PD-L1 inhibitor | 5/2016 (for advanced or metastatic UC that worsened during/after platinum chemotherapy), 6/2018 (for cisplatin-ineligible advanced or metastatic UC with high PD-L1 expression, or for advanced/metastatic UC ineligible for any platinum therapy), withdrawn 3/2021 | Rosenburg et al. (21), Necchi et al. (22), Galsky et al. (23) |
| Durvalumab | PD-L1 inhibitor | 2/2017 (for advanced or metastatic UC that progressed during/after platinum), withdrawn 2/2021 | Massard et al. (24), Powles et al. (25) |
| Nivolumab | PD-1 inhibitor | 2/2017 (for advanced or metastatic UC that worsened during/after platinum) | CheckMate trials (26–28) |
| Avelumab | PD-L1 inhibitor | 5/2017 (for advanced or metastatic UC that progressed during/after platinum or within 1 year of adjuvant/neoadjuvant platinum), 6/2020 (for maintenance treatment of advanced/metastatic that has not progressed after platinum) | Apolo et al. (29), Patel et al. (30), JAVELIN Bladder 100 (NCT02603432) |
| Pembrolizumab | PD-L1 inhibitor | 5/2017 (for advanced or metastatic UC that progressed during/after platinum), 6/2018 (for cisplatin-ineligible advanced or metastatic UC with high PD-L1 expression, or for advanced/metastatic UC ineligible for any platinum therapy), 1/2020 (for high-risk BCG-unresponsive NMIBC) | KEYNOTE trials (31–35) |
| Erdafitinib | FGFR inhibitor | 4/2019 (for advanced or metastatic UC with FGFR 2 or 3 that progressed after platinum) | Bahleda et al. (36), Loriot et al. (37) |
| Enfortumab vedotin | ADC targeting Nectin-4 | 12/2019 (for advanced or metastatic UC that progressed after two prior therapies) | Rosenburg et al. (38, 39) |
| Sacituzumab govitecan | ADC targeting Trop-2 | 4/2021 (for advanced or metastatic UC previously treated with platinum or PD-1/PD-L1) | Faltas et al. (40), TROPHY trial (NCT03547973) |
The novel FDA-approved therapies for the treatment of UC since 2015 are listed here in chronological order of approval, with the supporting literature referenced for each. Atezolizumab and durvalumab were both withdrawn in early 2021.