MARLBOROUGH, Mass.,
March 18, 2021 /PRNewswire/
-- Boston Scientific Corporation (NYSE: BSX) announced it has
received U.S. Food and Drug Administration (FDA) approval of the
TheraSphere™ Y-90 Glass Microspheres,
developed for the treatment of patients with hepatocellular
carcinoma (HCC). The approval expands access to this
life-prolonging therapy for a greater number of patients, which, to
date, has been utilized under a humanitarian device exemption (HDE)
– an FDA classification which required institutional review board
approval and limited the number of patients treated with the
therapy per year. TheraSphere is now the only radioembolization
technology indicated for the treatment of unresectable HCC in the
U.S.
HCC is one of the most prevalent cancers in the world and the
most common type of primary liver cancer, with more than half a
million new global cases diagnosed annually.i The
American Cancer Society estimates that approximately 32,000 new
cases of HCC will be diagnosed in the U.S. in 2021.ii It
is most often treated through surgery, liver transplantation,
chemotherapy or embolization, including both chemoembolization and
radioembolization – also commonly referred to as selective internal
radiation therapy (SIRT). TheraSphere treatment, a type of SIRT
with low toxicity, is comprised of millions of microscopic glass
beads containing radioactive yttrium (Y-90), which are delivered directly to liver
tumors via catheter and result in minimal exposure to surrounding
healthy tissue.
Approval of TheraSphere was based on results from the LEGACY
study, designed to evaluate the safety and efficacy of the therapy
for the treatment of early and advanced HCC. The study analyzed
data from 162 patients and met both primary endpoints of objective
response rate and duration of response rate (72.2% at four weeks
and 76.1% at six months, respectively).iii, iv,v,vi Data
demonstrated 100% complete or partial patient response up to two
TheraSphere treatments – disappearance of all lesions or >/= 30%
decrease in target lesion diameter – and a 93% overall survival
rate in patients with transplant or resection following treatment
at three years.
"I am honored to have spearheaded the LEGACY trial in which we
found that patients with early and advanced HCC exhibited very high
response rates as well as clinically meaningful durations of
response and survival, establishing TheraSphere as a standard
treatment for this patient population," said Riad Salem, M.D., M.B.A, interventional
radiologist at Northwestern Memorial Hospital and principal
investigator of the LEGACY trial. "The trial results, which have
been accepted for publication in Hepatology, produced one of
the most comprehensive databases for TheraSphere, empowering
physicians to make informed, data-driven decisions for their
patients."
Treatment with TheraSphere does not require hospitalization and
is typically performed as an outpatient procedure in as little as
an hour, potentially alleviating pressure on healthcare systems in
an increasingly complex care environment. Recognition of the
benefits of SIRT – both to patients and hospitals – were reflected
in recently issued guidance from the National Institute for Health
and Care Excellence (NICE) when they recommended the use of
TheraSphere for the treatment of patients with HCC through the
National Health Service (NHS) in England, Wales and Northern
Ireland.
"The FDA approval and the recent NICE recommendation will expand
access to TheraSphere, which has demonstrated improvement in both
survivability and quality of life through 20 years of clinical
trials and real-world outcomes in the more than 70,000 patients
globally," said Peter Pattison,
president of Interventional Oncology, Peripheral Interventions,
Boston Scientific. "We expect to continue to focus our efforts on
bringing this treatment to more patients, both by planning a
randomized trial to study the combination of TheraSphere and
immunotherapy in patients with HCC not eligible for curative
treatments, as well as further investigating the therapy for
different cancer segments, including prostate and brain."
For more information on TheraSphere, visit
www.therasphere.com.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for more than 40 years, we
advance science for life by providing a broad range of high
performance solutions that address unmet patient needs and reduce
the cost of healthcare. For more information, visit and connect on
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CONTACTS:
Karin Dalsin
Media Relations
(763) 494-1914 (office)
Karin.Dalsin@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5670 (office)
BSXInvestorRelations@bsci.com
i Mittal S, El–Serag HB. Epidemiology of
hepatocellular carcinoma: consider the population. J Clin
Gastroenterol. 2013; 47(suppl): S2– S6.
ii Cancer Facts & Figures 2021. American Cancer
Society. Available at
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-fact-and-figures/2021/cancer-facts-and-figures-2021.pdf.
Accessed: January 30, 2021.
iii Complete Response (CR) and Partial Response (PR)
within the treatment area according to localized mRECIST
iv Duration of Response (DoR) According to localized
mRECIST
v Objective Response Rate defined as CR or PR using
localized mRECIST (defined as the response within theY-90 glass
microsphere treatment area) with confirmation of response (>4
weeks)
vi Duration of Response using localized mRECIST
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SOURCE Boston Scientific Corporation