CHMP recommends approval for BRUKINSA plus
obinutuzumab as a treatment for adult patients who have received at
least two prior lines of therapy
If approved, BRUKINSA will be the first and
only BTK inhibitor approved for follicular lymphoma
BeiGene (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global
biotechnology company, today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) issued a positive opinion recommending approval of
BRUKINSA® (zanubrutinib), a Bruton’s tyrosine kinase inhibitor
(BTKi), 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.
“Follicular lymphoma remains an incurable disease and an ongoing
challenge for healthcare providers. Despite advances in the
treatment landscape, patients often relapse and experience shorter
response times to subsequent treatments,” said Mehrdad Mobasher,
M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene.
“Today’s positive CHMP opinion is a testament to our continued
commitment to bringing innovative medicines to patients and
demonstrates the value of BRUKINSA, which – if approved in FL –
will become the BTK inhibitor with the broadest label in the
EU.”
The CHMP recommendation is based on positive results from the
ROSEWOOD study and supported by the BGB-3111-GA101-001 study. The
pivotal ROSEWOOD study (BGB-3111-212; NCT03332017) is an ongoing
global 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 randomized,
open-label 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.
BRUKINSA plus obinutuzumab was generally well-tolerated, with
safety results consistent with previous studies of both medicines.
BGB-3111-GA101-001 (NCT02569476) is a Phase 1b study designed to
assess the safety, tolerability and antitumor activity of BRUKINSA
with obinutuzumab in participants with B-cell lymphoid
malignancies.
Following the CHMP positive opinion, the European Commission
will consider BeiGene’s Marketing Application, with a final
decision expected within 67 days. The decision will be applicable
to all 27 member states of the European Union (EU), plus Iceland
and Norway.
BRUKINSA is currently approved in the EU as monotherapy for the
treatment of adult patients with chronic lymphocytic leukemia and
as monotherapy for the treatment of adult patients with marginal
zone lymphoma who have received at least one prior anti-CD20-based
therapy. It is also approved in the EU for the treatment of adult
patients with Waldenstr�m’s macroglobulinemia who have received at
least one prior therapy or for the first-line treatment of patients
unsuitable for chemo-immunotherapy.
BeiGene currently has submissions for BRUKINSA in R/R FL under
review by regulatory authorities in the United States 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.
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 approvals 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.
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,iiii
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, Cambridge, and 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 commitment to bring innovative medicines to patients;
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.
ivCarton, G, et al., Time for an Individualized Approach to
First-Line Management of Follicular Lymphoma. Haematologica. 2022.
Vol 107 No. 1.
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Investor Contact: Liza Heapes +1 857-302-5663
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