Pembrolizumab: On January 8, 2020, pembrolizumab (Keytruda) was approved by the U.S. Food and Drug Administration (FDA) for Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk, non–muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1
Enfortumab Vedotin-ejfv: On December 18, 2019, enfortumab vedotin-ejfv (Padcev) was granted accelerated approval by the FDA to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.2
Erdafinitib: On April 12, 2019, erdafitinib (Balversa) was granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, when the disease has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
1. Balar AV, et al: 2019 Genitourinary Cancers Symposium. Abstract 350. Presented February 15, 2019.
2. Rosenberg JE, et al: J Clin Oncol 37:2592-2600, 2019.
3. U.S. FDA: Available at www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm635910.htm. Accessed May 7, 2019.