BRUKINSA is the first and only Bruton’s
Tyrosine Kinase (BTK) inhibitor for marginal zone lymphoma approved
in the European Union
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the European Commission
(EC) has granted marketing authorization of BRUKINSA®
(zanubrutinib) for the treatment of adult patients with
relapsed/refractory (R/R) marginal zone lymphoma (MZL) who have
received at least one prior anti-CD20-based therapy. The approval
is applicable to all 27 member states of the European Union (EU),
plus Iceland and Norway. BeiGene is focused on developing
innovative and affordable oncology medicines to improve treatment
outcomes and access for patients worldwide.
Notably, the EC granted an additional year of marketing
protection because the data submitted for the therapeutic
indication demonstrated a significant clinical benefit for BRUKINSA
in comparison with existing therapies.
“We are proud of what this approval means for European MZL
patients, who previously did not have an approved BTK inhibitor as
a treatment option for this rare hematological malignancy,” said
Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology
at BeiGene. “This milestone builds on the track record we’ve built
with BRUKINSA to date, with approvals in more than 55 countries and
regions, as we continue to fulfill our commitment to build a
transformational global R&D model that enables broader, faster
access to novel medicines.”
The EC approval follows a positive opinion granted in September
by the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) based on results from the
multicenter, global, single-arm, open-label, Phase 2 MAGNOLIA trial
in patients with R/R MZL who received at least one anti-CD-20 based
regimen. In the trial, BRUKINSA achieved a high overall response
rate of 68% with 26% of patients achieving complete remission, as
assessed by an Independent Review Committee (IRC). Responses were
observed in all patients regardless of MZL subtypes. BRUKINSA also
delivered rapid and durable disease control with a median time to
response of 2.8 months.i
BRUKINSA was generally well-tolerated and safety in MZL was
consistent with its established profile. The most common grade ≥3
adverse events (>5%) included neutropenia (23%), pneumonia
(11%), thrombocytopenia (8%) and anemia (8%). There were low rates
of discontinuation due to adverse events at 3.5%, highlighting that
BRUKINSA continued to be well-tolerated.ii
“This milestone marks the first and only approved BTK inhibitor
for marginal zone lymphoma in Europe,” comments Pier Luigi Zinzani,
MD., PhD., Full Professor of Haematology at the Institute of
Haematology “Seràgnoli”, University of Bologna, Italy. “As there is
no current standard of care in Europe, the approval of BRUKINSA
provides a chemotherapy-free treatment option for people with MZL
that has shown meaningful efficacy with durable and high response
rates across MZL subtypes.”
Gerwin Winter, Senior Vice President, Head of Europe at BeiGene,
notes, “We are excited to bring the first and only BTKi approved
for MZL to patients in Europe and look forward to continuing to
work with our growing and dedicated teams to make our medicine
accessible to patients who need them across Europe.”
BRUKINSA is also approved in the EU for the treatment of adult
patients with Waldenstr�m’s macroglobulinemia (WM) who have
received at least one prior therapy or for the first-line treatment
of patients unsuitable for chemo-immunotherapy, and last month,
CHMP issued a positive opinion recommending approval of BRUKINSA
for the treatment of adult patients with chronic lymphocytic
leukemia (CLL).
BeiGene has obtained reimbursement for BRUKINSA for the
treatment of WM in Austria, Belgium, Denmark, England and Wales,
Germany, Italy, Iceland, Ireland, The Netherlands, Spain, and
Switzerland, while additional countries across Europe are currently
going through the reimbursement process.
About Marginal Zone Lymphoma MZL is a group of
ultra-rare, slow growing B-cell malignancies that begin in the
marginal zones of lymph tissue.iii Epidemiological data from Europe
is limited, but the incidence rate of MZL is estimated to range
between 20 and 30 per million per year.iv,v,vi There are three
different subtypes of MZL: extranodal marginal zone B-cell
lymphoma, or mucosa-associated lymphoid tissue (MALT), which is
most common; nodal marginal zone B-cell lymphoma which develops in
the lymph nodes and is rare; and splenic marginal zone B-cell
lymphoma which develops in the spleen, bone marrow, or both, and is
the rarest form of the disease.vii
About BRUKINSA 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. BRUKINSA was specifically
designed to deliver targeted 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.
BRUKINSA is supported by a broad clinical program which includes
more than 4,500 subjects in 35 trials across 28 markets. To date,
BRUKINSA has received approvals covering more 55 countries and
regions, including the United States, China, the EU, Great Britain,
Switzerland, Canada, Australia, and additional international
markets.
BeiGene Oncology BeiGene is committed to advancing best-
and first-in-class clinical candidates internally or with
like-minded partners to develop impactful and affordable medicines
for patients across the globe. We have a growing R & D and
medical affairs team of approximately 3,300 colleagues dedicated to
advancing more than 100 clinical trials that have involved more
than 16,000 subjects. Our expansive portfolio is directed
predominantly by our internal colleagues supporting clinical trials
in more than 45 countries and regions. Hematology-oncology and
solid tumor targeted therapies and immuno-oncology are key focus
areas for the Company, with both mono- and combination therapies
prioritized in our research and development. BeiGene currently has
three approved medicines discovered and developed in our own labs:
BTK inhibitor BRUKINSA in the U.S., China, the European Union,
Great Britain, Switzerland, Canada, Australia, and additional
international markets; and the non-FC-gamma receptor binding
anti-PD-1 antibody, tislelizumab, as well as the PARP inhibitor,
pamiparib, in China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor, ociperlimab, that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
Oncology products across designated regions of China.
About BeiGene BeiGene is a global biotechnology company
that is developing and commercializing innovative and affordable
oncology medicines to improve treatment outcomes and access for far
more 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 9,000 colleagues
spans five continents, with administrative offices in Beijing,
China; Cambridge, U.S.; and Basel, Switzerland. To learn more about
BeiGene, please visit www.beigene.com and follow us on 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 potential for
BRUKINSA to provide clinical benefit to patients with MZL, the
future development, regulatory filing and approval,
commercialization, and market access of BRUKINSA in the European
Union and other markets, the potential commercial opportunity for
BRUKINSA, and BeiGene’s plans, commitments, aspirations, and goals
under the headings “BeiGene Oncology” and “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 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 and commercialization of its drug candidates and
achieve and maintain profitability; and the impact of the COVID-19
pandemic on BeiGene’s clinical development, regulatory, commercial,
manufacturing, and other operations, as well as 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.
References i Opat S, Tedeschi A, Linton K, et al. The
MAGNOLIA Trial: Zanubrutinib, a Next-Generation Bruton Tyrosine
Kinase Inhibitor, Demonstrates Safety and Efficacy in
Relapsed/Refractory Marginal Zone Lymphoma. Clin Cancer Res. 2021
Dec 1;27(23):6323-6332. ii BRUKINSA®(zanubrutinib). Summary of
product characteristics; 2022. iiiAnnals of Oncology, Marginal Zone
Lymphomas: ESMO Clinical Practice Guidelines for diagnosis,
treatment and follow-up, January 6, 2020. iv Cerhan, J.R. and T.M.
Habermann, Epidemiology of Marginal Zone Lymphoma. Ann Lymphoma,
2021. v Smith, A., et al., Lymphoma incidence, survival and
prevalence 2004-2014: sub-type analyses from the UK's
Haematological Malignancy Research Network. Br J Cancer, 2015.
112(9): p. 1575-84. vi Maynadie, M., et al., Splenic Marginal Zone
Lymphoma: French Registries Population-Based Treatment and Survival
Analyses (2002-2014). Blood, 2020. 136. vii Leukemia & Lymphoma
Society, Marginal Zone Lymphoma. Available at:
https://www.lls.org/research/marginal-zone-lymphoma-mzl.
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Investor Kevin Mannix +1 240-410-0129 ir@beigene.com
Media Maryline Iva +41 616 852 090 media@beigene.com
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