MFDS approves Janssen’s urothelial cancer treatment Balversa

[Newsmp] The Ministry of Food and Drug Safety of South Korea (MFDS, Minister Oh Yoo-kyung) granted Janssen Korea’s orphan drug Balversa to treat urothelial cancer on Nov. 24.

Balversa (Erdafitinib) is a drug that inhibits the proliferation of cancer cells overexpressed due to fibroblast growth factor receptor (FGFR) mutations involved in cell growth and differentiation.

It is expected to provide a new treatment option for patients whose diseases have progressed after receiving existing chemotherapies.

The approved indication for Balversa is adult patients with locally advanced or metastatic urothelial cancer with FGFR2 or FGFR3 genetic alternations that 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.