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New!! FGFR Companion Diagnostic assay for Urothelial Cancer

Posted on May 07, 2019 by nmorton

Molecular Pathology Laboratory Network Inc. now offers evaluation of FGFR alterations for treatment of urothelial carcinoma with BALVERSA™ (erdafitinib)
On April 12, 2019 FDA approved Janssen’s Balversa™ (erdafitinib) for treatment for adult patients with locally advanced or metastatic urothelial carcinoma with known FGFR3 or FGFR2 alterations, that has progressed during or following prior platinum-containing chemotherapy.  The Qiagen Therascreen FGFR assay is the FDA-approved companion diagnostic for detecting the FGFR alterations which confer sensitivity to BALVERSA.

Clinical Utility
Urothelial carcinoma (UC), also known as transitional carcinoma, is the most common form of bladder cancer.  Of the ~ 80,000 new cases of bladder cancer per year, about 20% of the patients muscle-invasive or metastatic disease (Dietrich & Srinivas, 2018).  Across all UC, ~20% of specimens contain activating FGFR3 alterations or FGFR fusions fulfilling candidacy requirements for treatment with BALVERSA™.  In clinical trials patients treated with BALVERSA™ demonstrated a 32.2 % objective response rate (2.3% achieving a complete response and 29.9% achieving a partial response) (BALVERSA Prescribing Information). 
This assay is specifically designed to test urothelial cancer (UC) specimens preserved in FFPE.

Fibroblast growth factor receptors (FGFRs) are signaling pathway tyrosine kinases (transmembrane receptors) which play a role in controlling cell proliferation and differentiation (Tiong, Mah, & Leong, 2013).  Activated FGFRs phosphorylate specific tyrosine residues activate multiple pathways including RAS-MAPK, PI3K-AKT, PLCγ and STAT. Deregulation of FGFR signaling can promote tumorigenesis and is thus an attractive target for cancer therapies (Chae, et al., 2017).  Activating fusion and point mutation alterations within the FGFR2 and FGFR3 genes are present in some urothelial cancer patients (Williams, Hurst, & Knowles, 2013; Rodriguez-Vida, et al., 2015) conferring an actionable target for pan-FGFR therapeutics.

Ordering Requirements
Order Test Code M FGFR
Turnaround Time 7 days
Specimen Requirements Urothelial Cancer specimens in FFPE
Storage and Handling Transport at ambient temperature (18-25°C)

BALVERSA Prescribing Information (2018).
Chae, Y. K., Ranganath, K., Hammerman, P. S., Vaklavas, C., Mohindra, N., Kalyan, A., . . . Giles, F. J. (2017). Inhibition of the fibroblast growth factor receptor (FGFR) pathway: the current landscape and barriers to clinical application. Oncotarget, 8, 16052-16074. Retrieved from
Dietrich, B., & Srinivas, S. (2018). Urothelial carcinoma: the evolving landscape of immunotherapy for patients with advanced disease. Research and reports in urology, 10, 7-16.
Rodriguez-Vida, A., Saggese, M., Hughes, S., Rudman, S., Chowdhury, S., Smith, N. R., . . . Arkenau, H.-T. (2015). Complexity of FGFR signalling in metastatic urothelial cancer. Journal of Hematology & Oncology, 8(1), 119. doi:10.1186/s13045-015-0221-6
Tiong, K. H., Mah, L. Y., & Leong, C.-O. (2013). Functional roles of fibroblast growth factor receptors (FGFRs) signaling in human cancers. Apoptosis, 18(12), 1447-1468. doi:10.1007/s10495-013-0886-7
Williams, S. V., Hurst, C. D., & Knowles, M. A. (2013). Oncogenic FGFR3 gene fusions in bladder cancer. Human molecular genetics, 22(4), 795-803. doi:10.1093/hmg/dds486


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