FDA approves erdafitinib for mUC with FGFR3 alterations

The FDA approved erdafitinib (Balversa, Janssen Biotech) for adults with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, according to a press release.
As per the approval, the FGFR3 alterations must be determined by an FDA-approved companion diagnostic test. In addition, the approval applies to patients with disease that progressed during or after treatment with one line of prior systemic therapy.
The Administration recommends an erdafitinib dose of 8 mg once daily. The dose may be increased to 9 mg once daily at 14 to 21 days based on

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