US Bioservices has been selected by Janssen Biotech, Inc. (Janssen) to dispense BALVERSA (erdafitinib). Janssen received U.S. Food and Drug Administration (FDA) approval for BALVERSA on April 12, 2019. BALVERSA is indicated for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) 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 platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum- containing chemotherapy.1 BALVERSA is the first FGFR kinase inhibitor approved by the FDA. BALVERSA is a once-daily, oral FGFR kinase inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.

Urothelial cancer is the most common and frequent form of bladder cancer, consisting of more than 90 percent of all bladder cancers.2 The relative five-year survival rate for patients with Stage IV metastatic bladder cancer is currently five percent. About one in five patients with advanced UC have a FGFR genetic alteration.4 FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival.5 A companion diagnostic has also been approved by the FDA to help identify the presence of FGFR alterations in the tumor tissue of patients with metastatic UC.

As a specialty pharmacy, US...

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