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The kinase inhibitor is already approved for patients who experienced recurrence following 1 or more lines of standard of care platinum-containing chemotherapy.
Balversa was granted accelerated approval for the treatment of adults with locally advanced or mUC with susceptible FGFR3 or FGFR2 genetic alterations and disease progression.
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.
The European Commission (EC) has granted conditional marketing authorisation (CMA) to the Janssen Pharmaceutical Companies of Johnson & Johnson’s Talvey.
/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted...