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FDA Approves Erdafitinib for Bladder Cancer

Jason M. Broderick @jasoncology
Published: Friday, Apr 12, 2019

The FDA has granted an accelerated approval to erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic bladder cancer with an FGFR3 or FGFR2 alteration that has progressed on platinum-containing chemotherapy. This is the first targeted therapy approved for metastatic bladder cancer.

The accelerated approval of erdafitinib in bladder cancer is contingent on the results of a confirmatory trial.
Balversa (erdafitinib) Prescribing Information. FDA. Accessed April 12, 2019. https://bit.ly/2X67iEm.

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