BRUKINSA is the first and only BTK inhibitor
approved for follicular lymphoma in the European Union
Approval was based on results from the ROSEWOOD
trial in which BRUKINSA plus the anti-CD20 monoclonal antibody
obinutuzumab achieved higher overall response rate compared to
obinutuzumab alone
BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the European Commission
(EC) has granted marketing authorization for BRUKINSA®
(zanubrutinib) in combination with obinutuzumab for the treatment
of adult patients with relapsed or refractory (R/R) follicular
lymphoma (FL) who have received at least two prior lines of
systemic therapy. This marks the fourth indication in the European
Union (EU) for BRUKINSA, which is now approved to treat more
patient populations in the EU than any other Bruton’s tyrosine
kinase (BTK) inhibitor.
“With this approval, we are excited to announce that BRUKINSA
will become available as a treatment option for patients with
follicular lymphoma in the European Union. BRUKINSA is now the
first BTK inhibitor approved in this indication and has the
broadest label of any medicine in its class globally,” said Mehrdad
Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at
BeiGene. “This milestone marks a significant advancement in our
efforts to combat the disease by providing a new and effective
treatment option to patients who have either failed to respond to
initial therapies or have experienced a relapse.”
The EC approval is based on positive results from ROSEWOOD
(NCT03332017), a global, randomized, open-label Phase 2 study of
BRUKINSA plus obinutuzumab compared with obinutuzumab alone in 217
patients with R/R FL who received at least two prior lines of
systemic therapy. In the study, the overall response rate was 69.0%
in the BRUKINSA plus obinutuzumab arm versus 45.8% in the
obinutuzumab arm (P = 0.0012), with a median follow-up of
approximately 20 months. Responses were durable with 18-month
landmark duration of response (DOR) of 69.3% in the BRUKINSA
combination arm.
Additionally, the median progression-free survival (PFS) for
patients treated with BRUKINSA plus obinutuzumab was 28.0 months,
compared to 10.4 months for patients treated with only obinutuzumab
(HR: 0.50 [95% CI: 0.33, 0.75]; P = 0.0007).
BRUKINSA plus obinutuzumab was generally well-tolerated, with
safety results consistent with previous studies of both
medicines.
“People living with follicular lymphoma often experience relapse
and have poor responses to subsequent lines of therapy, making it
imperative to improve outcomes,” said Pier Luigi Zinzani, M.D.,
Ph.D., Full Professor of Haematology at the Institute of
Haematology “Seràgnoli,” University of Bologna, Italy. “The results
from the ROSEWOOD trial demonstrated a significant clinical benefit
of BRUKINSA plus obinutuzumab for patients with relapsed or
refractory follicular lymphoma. BRUKINSA is a chemotherapy-free,
oral treatment option that can be a practice-changing option for
eligible patients with relapsed or refractory follicular
lymphoma.”
In addition to R/R FL, BRUKINSA is approved in the EU as
monotherapy for the treatment of adult patients with chronic
lymphocytic leukemia, for adult patients with marginal zone
lymphoma who have received at least one prior anti-CD20-based
therapy, and for adult patients with Waldenstr�m’s
macroglobulinemia who have received at least one prior therapy, or
in first-line treatment for patients unsuitable for
chemo-immunotherapy.
Gerwin Winter, Senior Vice President, Head of Europe at BeiGene
noted, “We have made great progress in making BRUKINSA available to
eligible patients with hematological malignancies globally, and
this approval is a testament to our continued commitment to bring
this much needed treatment option to patients in Europe and around
the world. We hope that this approval will have a positive impact
on the lives of many people living with follicular lymphoma in the
European Union and their families.”
BeiGene currently has submissions for BRUKINSA in R/R FL under
review by regulatory authorities including in the United States
(U.S.) and China. Additionally, BeiGene’s submission for BRUKINSA
in R/R FL is under review by regulatory authorities in Canada,
Switzerland, and the United Kingdom as part of the Access
Consortium New Active Substance Work-sharing Initiative
(NASWSI).
BRUKINSA is approved in more than 65 markets, including the
U.S., China, EU, Great Britain, Canada, Australia, South Korea, and
Switzerland in selected indications and under development for
additional indications globally. Product information may differ
from country to country. Prescribers should consult the product
information approved in their respective countries. The global
BRUKINSA development program includes more than 5,000 subjects
enrolled to date in 29 countries and regions.
The Summary of Product Characteristics for BRUKINSA can be found
here:
https://www.ema.europa.eu/en/documents/product-information/brukinsa-epar-product-information_en.pdf
About Follicular Lymphoma
FL is the second most common type of non-Hodgkin lymphoma (NHL),
accounting for 22 percent of all NHL cases.i Across Europe, over
122,000 people each year are diagnosed with NHL.ii FL is a
slow-growing cancer but can become more aggressive over time. While
FL remains incurable, people with the condition can live a long
time. The five-year survival rate is about 90 percent, and
approximately half of people diagnosed with FL can live with the
disease for nearly 20 years.iii,iv
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
affordable and accessible 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).
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
BeiGene’s ability to provide effective treatment options to
patients with FL; whether BRUKINSA is a practice-changing option
for eligible patients; the effect, if any, that the EC approval of
BRUKINSA for R/R FL will have on people living with R/R FL and
their families; BeiGene’s advancement, anticipated clinical
development, regulatory submissions and commercialization of
zanubrutinib, particularly as a treatment for R/R FL; 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.
References
iLeukemia & Lymphoma Society.
Treatment for Indolent NHL Subtypes. Available at:
https://www.lls.org/lymphoma/non-hodgkin-lymphoma/nhl-subtypes/treatment-indolent-nhl-subtypes.
iiWorld Health Organization. Non-Hodgkin
Lymphoma. Available at:
https://gco.iarc.fr/today/data/factsheets/cancers/34-Non-hodgkin-lymphoma-fact-sheet.pdf.
iiiAmerican Cancer Society. Survival Rates
and Factors That Affect Prognosis (Outlook) for Non-Hodgkin
Lymphoma. Available at:
https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/detection-diagnosis-staging/factors-prognosis.
ivCartron G and Trotman J. Time for an
Individualized Approach to First-Line Management of Follicular
Lymphoma. Haematologica. 2022;107(1):7-18.
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Investor: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kyle Blankenship +1 667-351-5176
Maryline Iva +41 61 685 20 90 media@beigene.com
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