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:
Opportunities for targeted therapies in solid tumors. Ann Oncol.
2014;25:552–563.
Contacts
Francesca Gunning, AmerisourceBergen
610-727-7433 – Office
215-603-9264
– Mobile
fgunning@AmerisourceBergen.com
Kate Rogers, Tierney Communications
215-790-4314 – Office
570-417-7644–
Mobile
krogers@tierneyagency.com