Janssen Submits NDA for Oral Pan-FGFR Inhibitor Erdafitinib (Balversa) in China for Advanced Urothelial Carcinoma

On December 15, the CDE website showed that Johnson & Johnson's erdafitinib (trade name: Balversa) tablet marketing application was accepted for the treatment of advanced urothelial carcinoma.

Erdafitinib is a pan-fibroblast growth factor receptor (FGFR) inhibitor taken orally once daily. In April 2019, the product received accelerated FDA approval for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) carrying FGFR2/3 mutations, whose disease progressed during or after platinum-based chemotherapy (including within one year of neoadjuvant or adjuvant chemotherapy). It became the world’s first FGFR inhibitor to gain FDA approval and the first targeted therapy for metastatic bladder cancer.

According to the PharmaCube database, the Phase III clinical trial (CTR20182097) of Erdafitinib for the treatment of advanced urothelial carcinoma was completed in October this year. The aim was to evaluate its efficacy and safety compared with chemotherapy or pembrolizumab in subjects with advanced urothelial carcinoma who have progressed after prior first-line treatment and carry specific FGFR abnormalities. The study recruited 629 participants internationally and 44 participants in China.

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