24 February 2020 - Diagnostic testing is available to identify which patients are most likely to benefit from BALVERSA, offering a personalized treatment approach in bladder cancer.

The Janssen Pharmaceutical Companies of Johnson & Johnson recently received Health Canada Notice of Compliance with conditions (NOC/c), approving BALVERSATM (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (UC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy.1 This approval marks the first oral FGFR kinase inhibitor approved by Health Canada for patients with locally advanced or metastatic urothelial carcinoma (bladder cancer).

Health Canada approved the therapy on the condition that Janssen Inc. carries out a confirmatory trial to verify the clinical benefit of BALVERSA.2 The NOC/c policy provides access to promising new drugs for patients diagnosed with serious, life-threatening or severely debilitating diseases, or conditions for which no drug is currently marketed in Canada, or for which a significant increase in efficacy or significant decrease in risk is demonstrated in relation to existing drugs marketed in Canada.

BALVERSATM, a once-daily oral FGFR kinase inhibitor, was issued an NOC/c based on results from a Phase 2 clinical trial (BLC2001, NCT02365597), a multicenter, 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 (R248C, S249C, G370C, Y373C) or FGFR gene fusions (FGFR3-TACC3, FGFR3- BAIAP2L1, FGFR2-BICC1, FGFR2-CASP7), as determined by a clinical trial assay performed at a central laboratory.

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