BRUKINSA is the first and only BTK inhibitor
approved for follicular lymphoma in Canada
- Follicular lymphoma (FL) is the 2nd most common type of
non-Hodgkin lymphoma (NHL)
- This is the fifth Canadian therapeutic indication for
BRUKINSA
TORONTO, Feb. 7, 2024
/CNW/ - BeiGene, Ltd. (Nasdaq: BGNE) (HKEX: 06160) (SSE: 688235), a
global biotechnology company, today announced it received Health
Canada authorization for the use of BRUKINSA®
(zanubrutinib) in combination with obinutuzumab for the
treatment of adult patients with relapsed or refractory grade 1, 2
or 3a follicular lymphoma (FL) who have received at least two prior
systemic therapies.
This marks the fifth hematology indication for BRUKINSA in
Canada following approvals for the
treatment of adult patients with Waldenström's macroglobulinemia
(WM); adult patients who have received at least one prior therapy
for the treatment of mantle cell lymphoma (MCL); adult patients
with relapsed or refractory marginal zone lymphoma (MZL) and adult
patients with chronic lymphocytic leukemia (CLL).
"Having a new safe, effective and well-tolerated treatment
choice for Canadians living with follicular lymphoma is an
important achievement," said Peter
Brenders, General Manager, BeiGene Canada. "We are hopeful
that even more patients can now benefit from BRUKINSA and are
proud to highlight BeiGene's unwavering commitment to improving
cancer patient outcomes and having a positive impact on their
lives."
The Canadian approval is based on positive results from ROSEWOOD
(NCT03332017), a pivotal global, randomized, open-label Phase 2
study comparing the highly selective Bruton's tyrosine kinase (BTK)
inhibitor BRUKINSA combined with obinutuzumab vs. obinutuzumab
alone. At 20.2 months the ROSEWOOD trial met its primary endpoint,
demonstrating a statistically significantly higher Objective
Response Rate (ORR), as assessed by the Independent Review
Committee (IRC). BRUKINSA plus obinutuzumab was generally
well-tolerated, with safety results consistent with previous
studies of both medicines and showed consistent benefit over
obinutuzumab in pre-specified subgroups. 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). 1,2,3
"Individuals living with follicular lymphoma often relapse or
may respond poorly to subsequent treatments," said Dr. Sarit Assouline, Hematologist, McGill University and Jewish General Hospital. "The
approval of BRUKINSA is a game changer with a demonstrated clinical
benefit that provides a chemotherapy-free oral medication option
for eligible patients with relapsed or refractory follicular
lymphoma."
"Lymphoma Canada is the only
national charity focused solely on lymphoma. Our goals
include raising awareness about lymphoma and amplifying the voices
of patients and their families in Canada," said Antonella Rizza, Chief Executive Officer of
Lymphoma Canada. "Approval of this therapy for relapsed or
refractory follicular lymphoma patients is exciting news for those
living with this blood cancer."
Follicular Lymphoma (FL) in
Canada
FL is the second most common type of non-Hodgkin lymphoma (NHL),
accounting for 22% of all NHL cases. While patients with FL may
experience very few symptoms or none at all, the most common
symptom is a painless swelling in the neck, armpit or groin regions
caused by enlarged lymph nodes. Patients may also experience
fatigue, loss of appetite, or itchy skin. FL is a slow-growing
cancer but can become more aggressive over time. While FL remains
incurable, individuals with this condition can live a long time. FL
usually occurs in people 50 years of age or older, and the average
age at diagnosis is 59. It is slightly more common in women than in
men. 4,5
About BRUKINSA
(zanubrutinib)
BRUKINSA blocks a specific protein in the body that helps cancer
cells live and grow. This protein is called "Bruton's Tyrosine
Kinase." By blocking this protein, BRUKINSA may help kill and
reduce the number of cancer cells and slow the spread of the
cancer. BRUKINSA 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. As new BTK protein
is continuously synthesized, BRUKINSA was specifically designed by
BeiGene 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 several disease relevant
tissues.
About BeiGene
Canada
Headquartered in Toronto, Ontario, BeiGene Canada is the country
affiliate of global biotechnology company BeiGene, specializing in
the discovery and development of novel, affordable and accessible
oncology medications. With a highly experienced and dedicated
Canadian leadership team headed by pharmaceutical
executive Peter Brenders, BeiGene Canada is committed to
delivering new cancer therapies to the Canadian oncology community,
including patients, caregivers, clinicians, and investigators. For
more information about BeiGene Canada please
visit www.beigene.ca.
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 more patients who need them. Our growing global
team of more than 10,000 colleagues spans five continents, with
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 myBeiGene®
Patient Support Program
The myBeiGene® patient support program is designed to
support patients, caregivers, and healthcare providers with access
to BRUKINSA. It goes beyond financial assistance support to provide
patients and caregivers with education about their disease and
treatment with BRUKINSA, as well as provide practical and emotional
support by connecting them to third-party resources that can
address their individual needs. Oncology Case Managers are
available Monday through Friday from 8 a.m.
to 8 p.m. Eastern Time at 1-833-234-4366.
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 a safe, effective and well tolerated
treatment for Canadians living with FL; the potential benefit of
BRUKINSA to patients with FL; BeiGene's commitment to improving
cancer patient outcomes; BeiGene's advancement and
commercialization of BRUKINSA; 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.
IMPORTANT SAFETY
INFORMATION
Indications & Clinical Use:
BRUKINSA (zanubrutinib) is indicated:
- for the treatment of adult patients with Waldenström's
macroglobulinemia (WM)
- for the treatment of adult patients with mantle cell lymphoma
(MCL) who have received at least one prior therapy
- for the treatment of adult patients with marginal zone lymphoma
(MZL) who have received at least one prior anti-CD20-based
therapy
- for the treatment of adult patients with chronic lymphocytic
leukemia (CLL)
- in combination with obinutuzumab for the treatment of adult
patients with relapsed or refractory grade 1, 2 or 3a follicular
lymphoma (FL) who have received at least 2 prior systemic
therapies.
Pediatrics (<18 years of age): No safety and efficacy
data are available; therefore, Health Canada has not authorized an
indication for pediatric use.
Geriatrics (>65 years of age): No clinically relevant
differences in safety or efficacy were observed between patients
≥65 years and those younger than 65 years.
Contraindications:
BRUKINSA is contraindicated in patients who are hypersensitive
to zanubrutinib or to any ingredient in the formulation, including
any non-medicinal ingredient, or component of the container.
Most Serious Warnings and Precautions:
Healthcare
professional supervision required: Treatment with BRUKINSA
should be initiated and supervised by a Qualified Healthcare
Practitioner experienced in the use of anticancer therapies.
Serious hemorrhage: (see the BRUKINSA Product Monograph,
WARNINGS AND PRECAUTIONS, Hemorrhage).
Other Relevant Warnings and Precautions:
Second
primary malignancies: Monitor patients for skin cancer and
advise patients to use sun protection.
Atrial fibrillation and flutter: Monitor for signs and
symptoms of atrial fibrillation and atrial flutter and manage as
appropriate.
Driving and operating machinery: Fatigue, dizziness,
and asthenia have been reported in some patients taking BRUKINSA
and should be considered when assessing a patient's ability to
drive or operate machines.
Cytopenias: Monitor complete blood counts regularly during
treatment.
Infections: Monitor patients for signs and symptoms of
infection and treat appropriately. Consider prophylaxis according
to standard of care in patients who are at increased risk for
infections.
Tumour lysis syndrome: Monitor patients closely and treat as
appropriate.
Peri-operative considerations: Consider the
benefit-risk of withholding BRUKINSA for 3 to 7 days pre- and
post-surgery depending upon the type of surgery and the risk of
bleeding.
Fertility: No data on the effects of BRUKINSA on fertility
in humans are available.
Teratogenic risk: Advise women of the potential hazard
to a fetus and to avoid becoming pregnant during treatment and for
at least 1 week after the last dose of BRUKINSA. Advise men to
avoid fathering a child while receiving BRUKINSA and for at least 3
months following the last dose of BRUKINSA.
Breastfeeding: Advise lactating women not to breastfeed
during treatment with BRUKINSA and for at least two weeks following
the last dose.
Interstitial lung disease (ILD): Monitor patients for
signs and symptoms of ILD.
Hemorrhage: Patients should be monitored for signs of
bleeding.
For More Information:
Please consult the BRUKINSA Product Monograph
at BRUKINSA.ca/PM for important information relating to
adverse reactions, drug interactions, and dosing information, which
have not been discussed in this piece.
The Product Monograph can also be made available by calling
1-877-828-5598.
References____________________________________________________________________________________________
1
|
BeiGene Clinical Data
Presentations at 2022 ASCO Annual Meeting Demonstrate Mature and
Growing Oncology Portfolio. Accessed July 7, 2023.
https://ir.beigene.com/news-details/?id=a04cfe0f-2879-4539-9c67-89cfdc388b60.
|
2
|
A Study Comparing
Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R
Follicular Lymphoma (ROSEWOOD). ClinicalTrials.gov. Accessed July
7,
2023.https://classic.clinicaltrials.gov/ct2/show/NCT03332017.
|
3
|
Zinzani PL, et al.
ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus
Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With
Relapsed or Refractory Follicular Lymphoma. J Clin Oncol. (Accepted
for publication).
|
4
|
https://cancer.ca/en/cancer-information/cancer-types/non-hodgkin-lymphoma/what-is-non-hodgkin-lymphoma/follicular-lymphoma
|
5
|
https://www.lymphoma.ca/wp-content/uploads/2021/08/LymphomaCanada_FactSheet_FL_Digital.pdf
|
SOURCE BeiGene