FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma

On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.

Read the full FDA press release here.

Posted 4/12/2019