Healthcare company Janssen Pharmaceutical Companies of Johnson & Johnson reported on Friday the receipt of the US Food and Drug Administration (FDA) accelerated approval for BALVERSA (erdafitinib) for treating adults with locally advanced or metastatic urothelial carcinoma (mUC), a form of bladder cancer.

BALVERSA ,which is now approved for locally advanced or metastatic urothelial carcinoma (mUC), which has susceptible fibroblast growth factor receptor (FGFR) 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, follows the US FDA's breakthrough therapy designation and priority review designation, added the company.

According to the company, BALVERSA (erdafitinib) is a once-daily, oral fibroblast growth factor receptor (FGFR) kinase inhibitor indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC).

The company added that BALVERSA received accelerated approval based on results from its Phase 2 clinical trial (BLC2001, NCT02365597), a multicentre, open-label, single-arm study, of 87 patients with disease that had progressed on or after at least one prior chemotherapy and that had at least one of the following genetic alterations: FGFR3 gene mutations or FGFR gene fusions as determined by a clinical trial assay performed at a central laboratory. The results demonstrated a 32.2% objective response rate (ORR) as assessed by Blinded Independent Review Committee (BIRC).

Also, the company said it is offering BALVERSA and associated patient services through a single source specialty pharmacy provider, US Bioservices.