Adding to this, patients who had tumors that did not respond to BCG therapy also had no true alternative other than radical cystectomy.3
Over the last 2 years, we have seen rapid progress in the bladder cancer arena, with an explosion of clinical trials across all disease states. Five PD-1 and PD-L1 checkpoint inhibitors are now FDA-approved for the treatment of metastatic urothelial cancer, while a fibroblast growth factor receptor (FGFR) inhibitor and an antibody-drug conjugate each have received breakthrough designation status.4-10 Soon, results from additional registration trials are expected to further expand our options for treating both early-stage and advanced disease. This rapidly evolving landscape is incredibly exciting, but also creates a challenge as busy physicians struggle to keep track of numerous pivotal studies that have or will read out over such a compressed timeframe.
![1 Regulatory Approval Timeline advanced bladder therapies V3](/images/1_Regulatory_Approval_Timeline_-_advanced_bladder_therapies_V3.png)
![1 Regulatory Approval Timeline advanced bladder therapies V3](/images/2-advanced-UC-registration-trials_V3.jpg)
![1 Regulatory Approval Timeline advanced bladder therapies V3](/images/3-early-stage-UC-registration-trials_V4.jpg)
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Published Date: July 12th, 2019