BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced the National Institute for
Health and Care Excellence (NICE) of the United Kingdom (U.K.) has
issued a final draft guidance (FDG) recommending BRUKINSA®
(zanubrutinib) for the treatment of eligible adult patients
with:
- Untreated chronic lymphocytic leukemia (CLL) if there is a 17p
deletion or TP53 mutation (high risk) or
- Untreated CLL without a 17p deletion or TP53 mutation, and
fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus
rituximab (BR) is unsuitable and
- Relapsed or refractory CLL
“We are delighted that NICE has recognized the clinical and
economic benefit of BRUKINSA for patients with CLL,” said Dr.
Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene.
“This follows the previous approval of BRUKINSA by NICE in July
2022 as the only cost-effective treatment for patients with
Waldenstrom’s macroglobulinemia. Although we are a relatively new
player in the U.K. market, we are rapidly establishing ourselves as
a company that can make innovative cancer medicines accessible and
affordable for U.K. patients.”
As stated in the FDG, for the untreated CLL population that is
high-risk or for whom FCR or BR is unsuitable and for the
relapsed/refractory CLL population, zanubrutinib had lower
incremental costs and more incremental quality adjusted life years
compared with other BTK inhibitors. The committee considered that
zanubrutinib is a cost-effective use of NHS resources in CLL.
“This decision represents a significant milestone for patients
in England and Wales with CLL, the most common form of leukemia in
adults,” said Nick York, Patient Advocacy Healthcare Liaison
Officer, U.K. Leukemia Care. “Despite continued treatment advances,
many patients with CLL will relapse and need additional treatment
options. Furthermore, a proportion of patients have a disease which
is refractory to initial treatment.”
BRUKINSA is the third BTKi for CLL to be recommended by NICE for
routine commissioning.
“Zanubrutinib has demonstrated superior efficacy and a favorable
safety profile in two global Phase 3 trials, SEQUOIA and ALPINE, in
adult patients with CLL,” said Dr. Talha Munir, consultant
hematologist at Leeds Teaching Hospitals NHS Trust, Leeds, U.K.i,ii
“The positive recommendation from NICE will allow patients with CLL
in England and Wales to access this important new treatment
option.”
In addition, on October 9, 2023, BRUKINSA received approval by
the Scottish Medicines Consortium for the treatment of adult
patients with CLL in whom chemo-immunotherapy is unsuitable.
BRUKINSA is approved in more than 65 countries, including the
U.S., China, EU, Great Britain, Canada, Australia, South Korea, and
Switzerland, in selected indications and under development for
additional indications globally. The global BRUKINSA development
program includes more than 5,000 subjects enrolled to date in 29
countries and regions.
About Chronic Lymphocytic Leukemia (CLL) A
life-threatening cancer of adults, CLL is a type of mature B-cell
malignancy in which abnormal leukemic B lymphocytes (a type of
white blood cells) arise from the bone marrow and flood peripheral
blood, bone marrow, and lymphoid tissues.iii,iv CLL is the most
common type of leukemia in adults, accounting for about one-quarter
of new cases of leukemia.iv,v Approximately 3,800 people in the
U.K. are diagnosed with CLL every year.vi,vii
About BRUKINSA® (zanubrutinib) BRUKINSA is a small
molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by
BeiGene scientists that is currently being evaluated globally in a
broad clinical program as a monotherapy and in combination with
other therapies to treat various B-cell malignancies. Because new
BTK is continuously synthesized, BRUKINSA was specifically designed
to deliver complete and sustained inhibition of the BTK protein by
optimizing bioavailability, half-life, and selectivity. With
differentiated pharmacokinetics compared to other approved BTK
inhibitors, BRUKINSA has been demonstrated to inhibit the
proliferation of malignant B cells within a number of disease
relevant tissues.
About BeiGene BeiGene is a global biotechnology company
that is discovering and developing innovative oncology treatments
that are more accessible and affordable to cancer patients
worldwide. With a broad portfolio, we are expediting development of
our diverse pipeline of novel therapeutics through our internal
capabilities and collaborations. We are committed to radically
improving access to medicines for far more patients who need them.
Our growing global team of more than 10,000 colleagues spans five
continents, with administrative offices in Basel; Beijing; and
Cambridge, U.S. To learn more about BeiGene, please visit
www.beigene.com and follow us on LinkedIn and X (formerly known as
Twitter) at @BeiGeneGlobal.
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws, including statements regarding the clinical and
economic benefit of BRUKINSA for patients, particularly those with
CLL or Waldenstrom’s macroglobulinemia; BeiGene’s ability to make
innovative cancer medicines accessible and affordable for U.K.
patients; the future development, regulatory filing, approval and
commercialization of BRUKINSA; and BeiGene’s plans, commitments,
aspirations, and goals under the heading “About BeiGene.” Actual
results may differ materially from those indicated in the
forward-looking statements as a result of various important
factors, including BeiGene's ability to demonstrate the efficacy
and safety of its drug candidates; the clinical results for its
drug candidates, which may not support further development or
marketing approval; actions of regulatory agencies, which may
affect the initiation, timing, and progress of clinical trials and
marketing approval; BeiGene's ability to achieve commercial success
for its marketed medicines and drug candidates, if approved;
BeiGene's ability to obtain and maintain protection of intellectual
property for its medicines and technology; BeiGene's reliance on
third parties to conduct drug development, manufacturing,
commercialization, and other services; BeiGene’s limited experience
in obtaining regulatory approvals and commercializing
pharmaceutical products and its ability to obtain additional
funding for operations and to complete the development of its drug
candidates and achieve and maintain profitability; and those risks
more fully discussed in the section entitled “Risk Factors” in
BeiGene’s most recent quarterly report on Form 10-Q, as well as
discussions of potential risks, uncertainties, and other important
factors in BeiGene's subsequent filings with the U.S. Securities
and Exchange Commission. All information in this press release is
as of the date of this press release, and BeiGene undertakes no
duty to update such information unless required by law.
i Brown JR, Eichhorst B, Hillmen P, et al. Zanubrutinib or
Ibrutinib in Relapsed or Refractory Chronic Lymphocytic Leukemia. N
Engl J Med. 2023;388(4):319-332. doi:10.1056/NEJMoa2211582. ii Tam
CS, Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine and
rituximab in untreated chronic lymphocytic leukaemia and small
lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3
trial. Lancet Oncol. 2022;23(8):1031-1043. doi:
10.1016/S1470-2045(22)00293-5. iii National Cancer Institute.
Chronic Lymphocytic Leukemia Treatment (PDQ)–Patient Version.
Accessed October 2023.
https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq. iv
American Cancer Society. What is Chronic Lymphocytic Leukemia?
Updated May 10, 2018. Accessed October 2023.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
v American Cancer Society. Key Statistics for Chronic Lymphocytic
Leukemia. Updated January 12, 2023. Accessed October 2023.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
vi Cancer Research UK. Chronic Lymphocytic Leukaemia (CLL)
Incidence Statistics. Accessed October 2023.
https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence.
vii Leukaemia UK. Chronic Lymphocytic Leukaemia. Accessed October
2023.
https://www.leukaemiauk.org.uk/about-leukaemia/types-of-leukaemia/chronic-lymphocytic-leukaemia-cll/.
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version on businesswire.com: https://www.businesswire.com/news/home/20231020857447/en/
Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Maryline Iva +41 61 685 20 90 media@beigene.com
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