The Janssen Pharmaceutical Companies of Johnson & Johnson has filed a marketing authorisation application (MAA) with the European Medicines Agency for erdafitinib to treat locally advanced unresectable or metastatic urothelial carcinoma (UC).
The company is seeking approval to use the therapy to treat adult UC patients with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic mutations.
These patients should have advanced on or after receiving a minimum of one line of therapy comprising a programmed death receptor-1 or programmed death-ligand 1 inhibitor to be eligible to receive the treatment.
A once-a-day oral inhibitor of pan-fibroblast growth factor receptor (FGFR) tyrosine kinase, erdafitinib is being analysed in Phase II and III clinical trials in advanced UC patients.
The latest application is based on findings from cohort 1 of the Phase III THOR clinical trial assessing the safety and efficacy of erdafitinib compared with chemotherapy.
The trial met the primary endpoint of overall survival (OS), with study subjects in the erdafitinib arm demonstrating a median OS of more than one year at an interim analysis.
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Janssen Research & Development solid tumours clinical development vice-president Kiran Patel said: “Erdafitinib has demonstrated promising results in advanced, FGFR-altered UC, making this submission a vital step towards improving outcomes for patients in the future.
“The OS benefit we have seen with erdafitinib also supports the need for biomarker testing for FGFR alterations in all patients with metastatic UC.”
The US Food and Drug Administration (FDA) granted accelerated approval for erdafitinib in April 2019 for locally advanced or mUC treatment.
In August 2023, the company filed a supplemental new drug application with the regulator seeking full approval of the therapy based on data from the Phase III THOR study.
The FDA also approved Janssen’s Akeega for metastatic castration-resistant prostate cancer treatment.