FDA Approval Sought for Erdafitinib in Locally Advanced or Metastatic FGFR3+ Urothelial Carcinoma
A supplemental new drug application seeking the full approval of erdafitinib for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations who progressed during or following at least 1 line of a PD-1/PD-L1 inhibitor in the locally advanced or metastatic setting or within 12 months of neoadjuvant or adjuvant therapy, has been submitted to the FDA.
United States Peter Lebowitz Drug Administration Oncology At Janssen Research Development European Union Janssen Research
Source: onclive.com