FDA Okays First Targeted Drug for Metastatic Bladder Cancer

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FDA Okays First Targeted Drug for Metastatic Bladder Cancer

MEDSCAPE

PUBLISHED: 12 APRIL 2019

The US Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa, Janssen) for the treatment of locally advanced or metastatic bladder cancer with genetic alterations known as fibroblast growth factor (FGFR) 3 or 2. Erdafitinib is indicated for use in patients who have first progressed on platinum-containing chemotherapy. Also, patients must be selected for therapy with a newly approved companion diagnostic device, the therascreen FGFR RGQ RT-PCR Kit (Qiagen Manchester).