- BRUKINSA is now listed on the RAMQ and ODB formularies.
- Two global Phase 3 trials in adults with CLL demonstrated
superior efficacy for BRUKINSA in first line and
relapsed/refractory settings.
- Approximately 2,000 Canadians are diagnosed every year with
CLL, the most common form of leukemia in adults.
TORONTO, Jan. 31,
2024 /CNW/ - BeiGene, Ltd. (NASDAQ: BGNE) (HKEX:
06160) (SSE: 688235), a global biotechnology company is pleased
to announce that the Governments of Ontario and Quebec have publicly listed
BRUKINSA® (zanubrutinib), a second generation
inhibitor of Bruton's tyrosine kinase (BTK), for the treatment of
adults living with chronic lymphocytic leukemia (CLL), the
most common form of leukemia in adults. The Régie de
l'assurance maladie du Québec listing came into effect December 13, 2023, and the Ontario Drug Benefit
Program (ODB) added BRUKINSA on January 12,
2024.
CLL is a type of blood cancer that is incurable and slow
growing. The condition is more common in men and occurs mainly in
people over 60, with the average age of diagnosis in the early
70s.1 As there are no curative treatments for
individuals living with CLL, they require continual treatment.
During the course of their treatment, they might stop responding,
relapse or become intolerant to their medication.
BRUKINSA received its Notice of Compliance (NOC) for CLL
from Health Canada on May
24th, 2023. In addition to the new
ODB and RAMQ listings, it is available through private insurance
plans. BRUKINSA provides additional clinical benefit through
improved progression-free survival. It is also better tolerated and
has a favourable toxicity profile compared to current
chemoimmunotherapy and BTK inhibitor options.2,3,4
The Canadian Agency for Drugs and Technologies in Health (CADTH)
recommended BRUKINSA be listed on the provinces' public health
plans based on evidence from 2 ongoing phase lll, open-label
randomized controlled trials (RCTs) (SEQUOIA cohort 1 and ALPINE).
These trials demonstrated that treatment with zanubrutinib resulted
in added clinical benefit for patients with CLL. The SEQUOIA trial
cohort (N=479) demonstrated a statistically significant difference
(P<0.0001) in progression-free survival (PFS) between
zanubrutinib and bendamustine-rituximab treatment arms in patients
with treatment-naïve CLL. In the SEQUOIA trial, median PFS had not
yet been reached in the zanubrutinib arm, whereas in the
bendamustine-rituximab arm, the median PFS was 33.7 months (95%
confidence interval (CI), 28.1 months to not estimable (NE]). In
patients with r/r CLL, the ALPINE trial (N=652) demonstrated a
statistically significant difference (P = 0.0006) in overall
response rate (ORR) between the zanubrutinib and ibrutinib
treatment arms (78.3% and 62.5% respectively; HR = 1.25, 95% CI,
1.10 to 1.41), demonstrating noninferiority as well as superiority
of zanubrutinib to ibrutinib. 2
"Timely access to medicines like BRUKINSA cannot be
underestimated," said Dr. Christine
Chen, MEd, MD, FRCPC, Clinician Investigator, Princess
Margaret Cancer Centre. "This medication was approved by Health
Canada to treat patients with Chronic Lymphocytic
Leukemia based on its clear clinical benefit and superior
progression-free survival and now, thanks to the Government of
Ontario, it is accessible through
the ODB. This is such good news for patients, their families and
the physicians who treat them."
"I am excited by the decision of the Governments of Ontario and Quebec to provide CLL patients access to
BRUKINSA. This is a most welcome and significant development for
those living with this blood cancer," said Peter Brenders,
General Manager, BeiGene Canada. "Including innovative drugs on
pharmacare formularies is the foundation of good health care. Drug
access is a priority, and we are working closely with the other
provinces to include BRUKINSA on their public drug plans."
"We applaud the listing of BRUKINSA on the Ontario and Quebec provincial formularies which means that
CLL patients in these provinces will have access to this
medication," says Raymond Vles, Board Chair, CLL Canada.
"It is essential that Canadians are able to benefit from
approved treatments by way of public funding no matter where they
live, and we look forward to BRUKINSA being listed by the other
provinces."
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 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. Case managers are available
Monday through Friday from 8 a.m. to 8 p.m. Eastern Time at
1-833-234-4366.
About BeiGene Canada
Headquartered in Toronto, Ontario, BeiGene Canada is the country
affiliate of global biotechnology company BeiGene, specialized
in the discovery and development of novel, affordable and
accessible oncology medications. With a highly experienced and
dedicated Canadian leadership team, 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 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
the potential for BRUKINSA to provide clinical benefit to patients
with CLL, including being better tolerated and having a favourable
toxicity profile compared to other medicines; whether including
BRUKINSA on the Ontario and
Quebec provincial formularies will
provide greater access to patients; 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)
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 Lymphoma
Canada
www.lymphoma.ca/lymphoma/cll-sll/about-cll-sll/
|
2
https://canjhealthtechnol.ca/index.php/cjht/article/view/PC0310
|
3 Tam CS,
Brown JR, Kahl BS, et al. Zanubrutinib versus bendamustine
and rituximab in untreated chronic lymphocytic leukaemia and small
lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3
trial. Lancet Oncol. 2022;23(8):1031-1043.
|
4 Brown JR,
Eichhorst B, Hillmen P, et al. Zanubrutinib or ibrutinib in
relapsed or refractory chronic lymphocytic leukemia. N Engl J
Med. 2023;388(4):319-332.
|
SOURCE BeiGene Canada