The Ministry of Food and Drug Safety approved Janssen Korea’s orphan drug, “Balversa (erdafitinib),” to treat urinary tract epithelial cancer on Thursday.

Urinary tract epithelial cancer occurs in the epithelium (surface) of the urinary tract (through which urine passes), mostly in the bladder and occasionally in the renal pelvis and ureter.

Balversa Tab. is a medicinal product that suppresses the proliferation of overexpressed cancer cells due to the mutation of the fibroblast growth factor receptor (FGFR) involved in cell growth and differentiation. FGFRs are membrane receptors that regulate cell growth, survival, and differentiation, and their mutation causes various cancers.

Domestically approved benefits and effects of Balversa target adult patients with locally progressive or metastatic urinary tract epithelial cancer who have developed it after or during receiving one or more chemotherapies, including platinum-based ones or those who have developed it within 12 months of receiving pre- or post-operative adjuvant treatment, including platinum-based chemotherapy.

The ministry expected it to provide new treatment opportunities for patients who developed the disease after receiving existing treatments, including chemotherapy,

“We will try out best to expand treatment opportunities for patients with rare and intractable diseases by supplying treatments with proven safety and efficacy based on scientific and regulatory expertise,” it said.