Janssen Pharma Submits Marketing Authorisation Application For Erdafitinib

(RTTNews) - The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma, harbouring susceptible fibroblast growth factor receptor 3 genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand 1 inhibitor. The submission is based on results from the Phase 3 THOR study.

In April 2019, erdafitinib received accelerated approval from the FDA as a targeted therapy for adult patients with locally advanced or mUC with susceptible FGFR3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. On August 29, Janssen submitted a sNDA to the FDA seeking full approval of erdafitinib in this indication based on Cohort 1 of the Phase 3 THOR study.

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