BRUKINSA is now approved for the treatment of
MCL in 11 countries and regions, including the United States,
China, Canada, Australia, Brazil, the United Arab Emirates, and
Russia
BeiGene and NewBridge Pharmaceuticals are
working together to rapidly advance BRUKINSA in the Middle East and
North African (MENA) region
BeiGene (NASDAQ: BGNE; HKEX: 06160), a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide, and NewBridge Pharmaceuticals, a specialty
company in the Middle East and North Africa (MENA) regions
established to bridge the access gap by partnering with global
pharma and biotech companies, today announced that BRUKINSA®
(zanubrutinib) has received approval from the Saudi Food and Drug
Authority (SFDA) for the treatment of adult patients with mantle
cell lymphoma (MCL) who have received at least one prior therapy.
BeiGene and NewBridge Pharmaceuticals are working together to bring
BRUKINSA to healthcare providers and people living with MCL in
Saudi Arabia and other MENA markets following regulatory
approvals.
“Non-Hodgkin’s lymphoma is a leading cause of cancer incidence
and mortality in Saudi Arabia, representing a significantly unmet
need for those living with diseases, such as MCL. BRUKINSA is a
next-generation BTK inhibitor designed to improve tolerability
issues often associated with the class and has demonstrated
efficacy in clinical trials for patients with relapsed or
refractory MCL,” said Dr. Ahmad Absi, Hematology Section Head at
the National Guard Health Affairs in Jeddah, Kingdom of Saudi
Arabia.
“We are delighted that MCL patients in Saudi Arabia will now
have access to BRUKINSA, a potentially best-in-class BTK inhibitor.
Driven by our belief—Cancer has no borders. Neither do we, BeiGene
is committed to expanding access to high-impact medicines for all
patients who need them. With approval in Saudi Arabia and in the
United Arab Emirates earlier this year, we are working with
NewBridge Pharmaceuticals to bring BRUKINSA to more patients in the
MENA region,” commented Mohammed Al-Kapany, Senior Director of New
Markets in MENA at BeiGene.
“The approval of BRUKINSA in Saudi Arabia represents an
important milestone in our ongoing collaboration with BeiGene. With
this differentiated BTK inhibitor now approved in two markets in
the MENA region, we are one step closer to reaching patients living
with MCL with new treatment options,” remarked Joe Henein,
President and CEO of NewBridge Pharmaceuticals.
The recommended dose of BRUKINSA is either 160 mg twice daily or
320 mg once daily, taken orally with or without food. The dose may
be adjusted for adverse reactions and reduced for patients with
severe hepatic impairment and certain drug interactions.
About Mantle Cell Lymphoma (MCL)
Non-Hodgkin’s lymphoma (NHL) is the third most common cancer in
Saudi Arabia,1 with approximately 1,700 new cases in 2020.2 MCL is
rare form of NHL, accounting for five percent of all cases. It
develops in the outer edge of a lymph node called the mantle zone.
Mantle cell lymphoma occurs more often in men than in women. It is
usually diagnosed in people in their early 60s.3 MCL has a poor
prognosis, with a median survival of three to four years, and is
often diagnosed at a later stage of disease.4
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. 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.
BRUKINSA is approved in the following indications and
regions:
- For the treatment of mantle cell lymphoma (MCL) in adult
patients who have received at least one prior therapy (United
States, November 2019)*;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (China, June 2020)**;
- For the treatment of chronic lymphocytic leukemia (CLL) or
small lymphocytic lymphoma (SLL) in adult patients who have
received at least one prior therapy (China, June 2020)**;
- For the treatment of relapsed or refractory MCL (United Arab
Emirates, February 2021);
- For the treatment of Waldenstr�m’s macroglobulinemia (WM) in
adult patients (Canada, March 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy (China, June 2021)**;
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Canada, July 2021);
- For the treatment of MCL in adult patients who have received at
least one prior therapy (Chile, July 2021);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Brazil, August 2021);
- For the treatment of adult patients with WM (United States,
August 2021);
- For the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one anti-CD20-based regimen
(United States, September 2021)*;
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Singapore, October 2021);
- For the treatment of MCL in patients who have received at least
one prior therapy (Israel, October 2021);
- For the treatment of adult patients with WM who have received
at least one prior therapy, or in first line treatment for patients
unsuitable for chemo-immunotherapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received
at least one prior therapy (Australia, October 2021);
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Russia, October 2021); and
- For the treatment of adult patients with MCL who have received
at least one previous therapy (Saudi Arabia, November 2021).
To date, more than 20 marketing authorization applications have
been submitted for BRUKINSA for various indications.
* This indication was approved under accelerated approval based
on overall response rate. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
** This indication was approved under conditional approval.
Complete approval for this indication may be contingent upon
results from ongoing randomized, controlled confirmatory clinical
trials.
IMPORTANT U.S. SAFETY INFORMATION FOR BRUKINSA
(ZANUBRUTINIB)
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients
with hematological malignancies treated with BRUKINSA monotherapy.
Grade 3 or higher hemorrhage including intracranial and
gastrointestinal hemorrhage, hematuria and hemothorax have been
reported in 3.4% of patients treated with BRUKINSA monotherapy.
Hemorrhage events of any grade occurred in 35% of patients treated
with BRUKINSA monotherapy.
Bleeding events have occurred in patients with and without
concomitant antiplatelet or anticoagulation therapy.
Co-administration of BRUKINSA with antiplatelet or anticoagulant
medications may further increase the risk of hemorrhage.
Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA
if intracranial hemorrhage of any grade occurs. Consider the
benefit-risk of withholding BRUKINSA for 3-7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Infections
Fatal and serious infections (including bacterial, viral, or
fungal) and opportunistic infections have occurred in patients with
hematological malignancies treated with BRUKINSA monotherapy. Grade
3 or higher infections occurred in 27% of patients, most commonly
pneumonia. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jiroveci pneumonia and other infections according to standard of
care in patients who are at increased risk for infections. Monitor
and evaluate patients for fever or other signs and symptoms of
infection and treat appropriately.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (26%),
thrombocytopenia (11%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA
monotherapy. Grade 4 neutropenia occurred in 13% of patients, and
Grade 4 thrombocytopenia occurred in 3.6% of patients.
Monitor complete blood counts regularly during treatment and
interrupt treatment, reduce the dose, or discontinue treatment as
warranted. Treat using growth factor or transfusions, as
needed.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinoma, have
occurred in 14% of patients treated with BRUKINSA monotherapy. The
most frequent second primary malignancy was non-melanoma skin
cancer, reported in 8% of patients. Other second primary
malignancies included malignant solid tumors (4.0%), melanoma
(1.7%) and hematologic malignancies (1.2%). Advise patients to use
sun protection and monitor patients for the development of second
primary malignancies.
Cardiac Arrhythmias
Atrial fibrillation and atrial flutter were reported in 3.2% of
patients treated with BRUKINSA monotherapy. Patients with cardiac
risk factors, hypertension, and acute infections may be at
increased risk. Grade 3 or higher events were reported in 1.1% of
patients treated with BRUKINSA monotherapy. Monitor signs and
symptoms for atrial fibrillation and atrial flutter and manage as
appropriate.
Embryo-Fetal Toxicity
Based on findings in animals, BRUKINSA can cause fetal harm when
administered to a pregnant woman. Administration of zanubrutinib to
pregnant rats during the period of organogenesis caused
embryo-fetal toxicity including malformations at exposures that
were 5 times higher than those reported in patients at the
recommended dose of 160 mg twice daily. Advise women to avoid
becoming pregnant while taking BRUKINSA and for 1 week after the
last dose. Advise men to avoid fathering a child during treatment
and for 1 week after the last dose.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking this drug, the patient should be apprised of
the potential hazard to a fetus.
Adverse reactions
The most common adverse reactions, including laboratory
abnormalities, in ≥ 30% of patients who received BRUKINSA (N = 847)
included decreased neutrophil count (54%), upper respiratory tract
infection (47%), decreased platelet count (41%), hemorrhage (35%),
decreased lymphocyte count (31%), rash (31%) and musculoskeletal
pain (30%).
Drug Interactions
CYP3A Inhibitors: When BRUKINSA is co-administered with a
strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily.
For coadministration with a moderate CYP3A inhibitor, reduce
BRUKINSA dose to 80 mg twice daily.
CYP3A Inducers: Avoid coadministration with moderate or
strong CYP3A inducers.
Specific Populations
Hepatic Impairment: The recommended dose of BRUKINSA for
patients with severe hepatic impairment is 80 mg orally twice
daily.
Please see full U.S. Prescribing Information at
www.beigene.com/PDF/BRUKINSAUSPI.pdf and Patient Information at
www.beigene.com/PDF/BRUKINSAUSPPI.pdf.
BeiGene Oncology
BeiGene is committed to advancing hematology, immuno-oncology
and targeted therapies in order to bring impactful and affordable
medicines to patients across the globe. We have a growing R&D
team of approximately 2,300 colleagues dedicated to advancing more
than 90 clinical trials involving more than 13,000 patients and
healthy subjects. Our expansive portfolio is directed by a
predominantly internalized clinical development team supporting
trials in more than 40 countries or regions. We currently market
three medicines discovered and developed in our labs: BTK inhibitor
BRUKINSA in the United States, China, Canada, Australia and
additional international markets; and non-FC-gamma receptor binding
anti-PD-1 antibody tislelizumab and PARP inhibitor pamiparib in
China. BeiGene has a high quality, innovative science and medicine
organization and is a leader in China with a large oncology focused
commercial team.
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 and Bristol Myers Squibb. We also plan to address greater
areas of unmet need globally through our collaborations including
with Amgen, Bio-Thera, EUSA Pharma, Mirati Therapeutics, Seagen,
and Zymeworks. BeiGene has also entered into a collaboration with
Novartis granting Novartis rights to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
About BeiGene
BeiGene is a global, science-driven biotechnology company
focused on developing innovative and affordable medicines to
improve treatment outcomes and access for patients worldwide. With
a broad portfolio of more than 40 clinical candidates, we are
expediting development of our diverse pipeline of novel
therapeutics through our own capabilities and collaborations. We
are committed to radically improving access to medicines for two
billion more people by 2030. BeiGene has a growing global team of
over 7,700 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com and follow us on Twitter at
@BeiGeneGlobal.
About NewBridge Pharmaceuticals
NewBridge Pharmaceuticals is a regional specialty company with a
comprehensive pharmaceutical platform of services and expertise,
established to bridge the access gap and partner with global pharma
and biotech companies to in-license and commercialize U.S. Food and
Drug Administration or European Medicines Agency approved
innovative therapeutics that address unmet medical needs into the
Middle East and North Africa (MENA) regions.
For more information, please visit www.nbpharma.com.
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
plans for development and commercialization of BRUKINSA in Saudi
Arabia, MENA and other markets, the potential commercial
opportunity for BRUKINSA, plans for making BRUKINSA accessible to
patients in Saudi Arabia, MENA and other markets, the potential for
BRUKINSA to be a best-in-class BTK inhibitor and to provide
improved clinical benefits to patients, 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; the impact of the COVID-19 pandemic on the BeiGene’s
clinical development, regulatory, commercial, 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:
- Rauf MS, Akhtar S, Maghfoor I. Changing trends of adult
lymphoma in the Kingdom of Saudi Arabia - comparison of data
sources. Asian Pac J Cancer Prev. 2015;16(5):2069-72. doi:
10.7314/apjcp.2015.16.5.2069. PMID: 25773852.
- Globocan 2020. Available at
https://gco.iarc.fr/today/data/factsheets/populations/682-saudi-arabia-fact-sheets.pdf.
Accessed November 2021.
- Lymphoma Research Foundation. Understanding Mantle Cell
Lymphoma. Available at
https://lymphoma.org/wp-content/uploads/2018/10/MantleCellLymphomaFact-Sheet.pdf.
Accessed October 2021.
- Philip J. Bierman, James O. Armitage, in Goldman's Cecil
Medicine (Twenty Fourth Edition), 2012.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211114005288/en/
BeiGene
Investor Contact Gabrielle Zhou +86 10-5895-8058 or +1
857-302-5189 ir@beigene.com
Media Contact Emily Collins +1 201-201-4570
media@beigene.com
NewBridge Pharmaceuticals Rosie Khodeir +971 4 429 8700
rosie.khodeir@nbpharma.com
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