FRISCO, Texas--(BUSINESS WIRE)--US Bioservices, a specialty pharmacy that is a part of AmerisourceBergen, today announced that it 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.3 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.
"US Bioservices continues to stand out as a leader in specialty pharmacy, particularly in oncology care, and we are committed to providing unparalleled value for manufacturers, pharmacies and patients,” said Angela Ward, President of US Bioservices. “We are proud to work with Janssen to dispense this much-needed therapy to appropriate UC patients.”
As a specialty pharmacy, US Bioservices has more than two decades of experience supporting small patient populations and patients with various types of cancers. Through its Oncology Center of Excellence, US Bioservices’ dedicated Oncology Patient Support Team provides customized, high-touch services that address the unique clinical profile of this therapy and specific needs of the patient population. US Bioservices’ team of pharmacists and registered nurses provide therapy-specific education and 24/7 clinical support to patients and their caregivers.
Through the breadth of resources available at AmerisourceBergen, US Bioservices develops solutions to ensure patients on therapy receive specialized support to navigate their treatment, clinically, economically and socially.
BALVERSA is currently available only by submitting a prescription to US Bioservices. Physicians may submit prescriptions to US Bioservices via phone (877.757.0667), fax (888.899.0067), ePrescribe or the MyPathpoint Prescriber Portal.
About AmerisourceBergen
AmerisourceBergen provides pharmaceutical products, value-driving services and business solutions that improve access to care. Tens of thousands of healthcare providers, veterinary practices and livestock producers trust us as their partner in the pharmaceutical supply chain. Global manufacturers depend on us for services that drive commercial success for their products. Through our daily work — and powered by our 21,000 associates — we are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #12 on the Fortune 500, with more than $160 billion in annual revenue. The company is headquartered in Valley Forge, Pa. and has a presence in 50+ countries. Learn more at amerisourcebergen.com.
[1] BALVERSA Prescribing Information.
[2]National
Cancer Institute. NCI Dictionary of Cancer Terms. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/recist.
Accessed September 2018.
[3] Bladder Cancer:
Statistics. Available at: https://www.cancer.net/cancer-types/bladder-cancer/statistics.
Accessed September 2018.
[4] Siefker-Radtke, A, et al.
First results from the primary analysis population of the phase 2 study
of erdafitinib (ERDA; JNJ-42756493) in patients (pts) with metastatic or
unresectable urothelial carcinoma (mUC) and FGFR alterations (FGFRalt). Journal
of Clinical Oncology. Abstract #4503.
[5] Dienstmann
R, Rodon J, Prat A, et al. Genomic aberrations in the FGFR pathway:
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