Armenia and Nepal are the first of 29 countries
to receive BRUKINSA
The Max Foundation (Max), a global nonprofit organization
dedicated to accelerating health equity by delivering medication,
technology, and supportive services to patients worldwide, BeiGene,
a global oncology company, and the BeiGene Foundation, a nonprofit
charitable foundation, today announced that the first doses of
BRUKINSA® (zanubrutinib) have been administered for the treatment
of adult patients with chronic lymphocytic leukemia (CLL) to
patients in Armenia and Nepal, as part of a three-year
collaboration to provide access to the medicine in 29 low- and
middle-income countries (LMICs).
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“We are thrilled to share that the first group of people
diagnosed with CLL in Armenia and Nepal have received treatment
free of charge through our collaboration with BeiGene and the
BeiGene Foundation,” said Pat Garcia-Gonzalez, CEO of Max. “BeiGene
has demonstrated that it is possible for companies to provide
access to innovative treatments to regions in the world where
access is limited or unavailable during the same year a drug
receives approval in the U.S. We look forward to working together
to expand access to this much-needed treatment to more
patients.”
Last year, BeiGene joined Max’s Humanitarian Partnership for
Access to Cancer Treatments (Humanitarian PACT), a collaboration
among professional, nonprofit, and commercial organizations that
share the commitment to increase global access to treatment, care,
and support for people living with cancer. As a member of the
Humanitarian PACT, BeiGene provided a monetary grant through the
BeiGene Foundation and is providing BRUKINSA free of charge for
eligible patients in a number of low- and middle-income
countries.
“BeiGene and Max share a commitment to advance global health
equity and ensure that patients in underserved regions have access
to the best possible cancer care. The administration of the first
doses of BRUKINSA to patients with CLL in Armenia and Nepal under
our collaboration with Max and the BeiGene Foundation represents a
crucial step in achieving this mission,” said John V. Oyler,
Co-Founder, Chairman and CEO at BeiGene. “We are honored to
participate in this worthy collaboration and support Max’s efforts
to deliver innovative cancer medicines to patients in need around
the world.”
“For many years, the treatment of blood cancer, particularly
CLL, has posed and continues to pose a significant challenge in
Armenia. New medicines and treatments have simply not been
accessible to those in need,” said Karen Meliksetyan, M.D., Head of
Bone Marrow Transplant Department, Yeolyan Hematology and Oncology
Center, Yerevan, Armenia. “The donation of BRUKINSA presents a
tremendous opportunity for our patients to access treatment and
will have a positive impact on many patients.”
CLL is the most common leukemia in adults, accounting for about
one third of new cases of leukemia worldwidei. BeiGene and Max aim
to provide access to CLL treatment to patients in need in 29 low-
and middle-income countries. In each country, verified physicians
within Max’s network will submit a request for treatment to Max for
patients who are under their care and are candidates for BRUKINSA.
Upon patient identity verification and CLL diagnosis confirmation,
Max will deliver the treatment directly to the health institution
providing care to the patient through well-established supply
chains.
About The Max Foundation The Max Foundation is a global
health nonprofit organization dedicated to accelerating health
equity. For 26 years, Max has pioneered practical, scalable,
high-quality solutions to bring lifesaving treatments and
patient-centered health care to more than 100,000 people living
with cancer and critical illness in low- and middle-income
countries. Max believes in a world where all people can access
high-impact medicines, where geography is not destiny, and where
everyone can strive for health with dignity and with hope. Learn
more at www.themaxfoundation.org.
About BeiGene BeiGene is a global oncology company that
is discovering and developing innovative 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).
About the BeiGene Foundation The BeiGene Foundation is a
charitable organization established by BeiGene, Ltd. It is a
separate legal entity from BeiGene, Ltd. with distinct legal
restrictions. The foundation’s mission is to advance global health
by improving access to high quality therapies to more people around
the world focused on three strategic areas: health equity, disaster
relief, and community engagement.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Hemorrhage
Fatal and serious hemorrhage has occurred in patients with
hematological malignancies treated with BRUKINSA. Grade 3 or higher
hemorrhage including intracranial and gastrointestinal hemorrhage,
hematuria, and hemothorax was reported in 3.8% of patients treated
with BRUKINSA in clinical trials, with fatalities occurring in 0.2%
of patients. Bleeding of any grade, excluding purpura and
petechiae, occurred in 32% of patients.
Bleeding has occurred in patients with and without concomitant
antiplatelet or anticoagulation therapy. Coadministration 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 before and after
surgery depending upon the type of surgery and the risk of
bleeding.
Infections
Fatal and serious infections (including bacterial, viral, or
fungal infections) and opportunistic infections have occurred in
patients with hematological malignancies treated with BRUKINSA.
Grade 3 or higher infections occurred in 26% of patients, most
commonly pneumonia (7.9%), with fatal infections occurring in 3.2%
of patients. Infections due to hepatitis B virus (HBV) reactivation
have occurred.
Consider prophylaxis for herpes simplex virus, pneumocystis
jirovecii 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 (21%),
thrombocytopenia (8%) and anemia (8%) based on laboratory
measurements, developed in patients treated with BRUKINSA. Grade 4
neutropenia occurred in 10% of patients, and Grade 4
thrombocytopenia occurred in 2.5% 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. The most
frequent second primary malignancy was non-melanoma skin cancers
(8%), followed by other solid tumors in 7% of the patients
(including melanoma in 1% of patients) and hematologic malignancies
(0.7%). Advise patients to use sun protection and monitor patients
for the development of second primary malignancies.
Cardiac Arrhythmias
Serious cardiac arrhythmias have occurred in patients treated
with BRUKINSA. Atrial fibrillation and atrial flutter were reported
in 4.4% patients treated with BRUKINSA, including Grade 3 or higher
cases in 1.9% of patients. Patients with cardiac risk factors,
hypertension, and acute infections may be at increased risk. Grade
3 or higher ventricular arrhythmias were reported in 0.3% of
patients.
Monitor for signs and symptoms of cardiac arrhythmias (e.g.,
palpitations, dizziness, syncope, dyspnea, chest discomfort),
manage appropriately, and consider the risks and benefits of
continued BRUKINSA treatment.
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 (≥30%), including laboratory
abnormalities, in patients who received BRUKINSA (N=1729) are
decreased neutrophil count (51%), decreased platelet count (41%),
upper respiratory tract infection (38%), hemorrhage (32%), and
musculoskeletal pain (31%).
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 strong or
moderate CYP3A inducers. Dose adjustment may be recommended with
moderate 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
including U.S. Patient Information.
BeiGene’s 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 access to innovative treatments to regions with limited
access during the year a drug receives approval in the U.S.;
BeiGene’s ability to treat more patient pursuant to this
collaboration; BeiGene’s commitment to advance global health
equity; 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; BeiGene’s 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 annual report on
Form 10-K, 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 2 Yao Y, Lin X, Li F, Jin J,
Wang H. The global burden and attributable risk factors of chronic
lymphocytic leukemia in 204 countries and territories from 1990 to
2019: analysis based on the global burden of disease study 2019.
Retrieved from https://pubmed.ncbi.nlm.nih.gov/35016695/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240313093081/en/
Media: Eliza Schleifstein, The Max Foundation (917)
763-8106 eliza@schleifsteinpr.com
Kyle Blankenship, BeiGene media@beigene.com (667) 351-5176
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