Represents BRUKINSA’s second recent approval in
the Asia-Pacific region, following October 1 approval in Singapore
for treatment of patients with mantle cell lymphoma
The TGA approval is based on results from
ASPEN, an Australia-inclusive head-to-head clinical trial
evaluating BRUKINSA compared to ibrutinib in patients with
Waldenstr�m’s macroglobulinemia
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, today announced that BRUKINSA® (zanubrutinib)
has been approved in Australia for the treatment of adult patients
with Waldenstr�m’s macroglobulinemia (WM) who have received at
least one prior therapy or in first line treatment for patients
unsuitable for chemo-immunotherapy.1 Following registration of
BRUKINSA with the Therapeutic Goods Administration (TGA), these
patients will have immediate access to BRUKINSA through a BeiGene
sponsored post-approval, pre-reimbursement access program.
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In addition, BRUKINSA recently received approval from the
Singapore Health Sciences Authority (HSA) for the treatment of
adult patients with mantle cell lymphoma (MCL) who have received at
least one prior therapy.
“BTK inhibition is an established mode of treatment for patients
with WM, and the ASPEN trial showed that BRUKINSA is highly
effective and has improved tolerability compared to the
first-generation BTK inhibitor,” said Professor Con Tam, MBBS,
M.D., Disease Group Lead for Low Grade Lymphoma and Chronic
Lymphocytic Leukemia at the Peter MacCallum Cancer Centre and a
principal investigator on the BRUKINSA clinical program. “BeiGene
first began clinical trials of BRUKINSA in Australia in 2013, and
since that time, many Australians have benefitted from treatment as
part of ongoing clinical studies. We hope this therapy will offer
new hope for people living with WM in Australia.”
In Australia, more than 6,000 people are diagnosed with
non-Hodgkin’s lymphoma (NHL) each year, making it the sixth most
common cancer in adults.2 WM is a rare, slow-growing lymphoma that
occurs in less than two percent of patients with NHL.3 The disease
usually affects older adults and is primarily found in the bone
marrow, although it may also impact lymph nodes and the
spleen.3
“While WM is a slow-growing lymphoma, not all patients fully
respond to existing therapies and many discontinue treatment due to
side effects,” commented David Young, the National Team Leader at
the WMozzies. “We are pleased to hear that people living with WM in
Australia will have immediate access to this next-generation BTK
inhibitor that has demonstrated clinical benefit with potential to
improve treatment outcomes.”
BeiGene has submitted for reimbursement of WM to the
Pharmaceutical Benefits Advisory Committee (PBAC). In a first for
the PBAC, BeiGene expects to enter a facilitated resolution pathway
in order to seek a listing date for the WM indication.
“BRUKINSA has been shown to induce deep and durable responses
with reduced off-target side effects, suggesting improved clinical
benefit compared to standard BTK inhibitor therapy,” said Jane
Huang, M.D., Chief Medical Officer, Hematology at BeiGene. “We are
grateful to the Australian investigators, patients and families who
participated in clinical trials contributing to TGA approval. Our
ability to offer BRUKINSA to people in Australia impacted by WM is
another step toward fulfilling our goal of increasing affordable
access to oncology medicines around the world.”
“This approval in Australia, and our recent approval in
Singapore, represent BRUKINSA’s continued expansion in the APAC
region,” added Adam Roach, Vice President and Head of Commercial
for APAC (ex-Greater China) at BeiGene. “We have been building
commercial teams in these markets to support our goal of bringing
this potential best-in-class BTK inhibitor to patients who need
them globally.”
The Australian registration for BRUKINSA in WM is based on
efficacy results from the ASPEN clinical trial, a Phase 3
randomised, open-label, multicentre trial (NCT03053440) that
evaluated BRUKINSA compared to ibrutinib in patients with relapsed
or refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88
mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a
numerically higher very good partial response (VGPR) rate (28.4%,
95% CI: 20, 38) compared to ibrutinib (19.2%, 95% CI: 12, 28),
although the primary endpoint of statistical superiority related to
deep response (VGPR or better) was not met.
In the ASPEN trial, of the 101 patients with WM randomized and
treated with BRUKINSA, 5% of patients discontinued due to adverse
events, including cardiomegaly, neutropenia, plasma cell myeloma,
and subdural haemorrhage. Adverse events leading to dose reduction
occurred in 14.9% of patients, with the most common being
neutropenia (3.0%) and diarrhea (2.0%).
The overall safety profile of BRUKINSA is based on pooled data
from 779 patients with B-cell malignancies treated with BRUKINSA in
clinical trials. The most common adverse reactions (≥20%) with
BRUKINSA were neutropenia, thrombocytopenia, upper respiratory
tract infection, haemorrhage/haematoma, rash, bruising, anaemia,
musculoskeletal pain, diarrhea, pneumonia, and cough. The most
common Grade 3 or higher adverse reactions (≥5%) were neutropenia,
thrombocytopenia, pneumonia, and anaemia.
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 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
synthesised, BRUKINSA was specifically designed to deliver complete
and sustained inhibition of the BTK protein by optimising
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 United States, China, Australia,
Canada, and other international markets in selected indications and
under development for additional approvals globally.
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 internalised 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, 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
organisation 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
commercialise 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
commercialise 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 7,000 colleagues across five continents. To learn more about
BeiGene, please visit www.beigene.com.au and follow us on Twitter
at @BeiGeneGlobal.
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 commercialisation of BRUKINSA in
Australia, Singapore, the APAC region and other markets, the
potential commercial opportunity for BRUKINSA, plans for making
BRUKINSA accessible to patients in Australia, 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 commercialising
pharmaceutical products and its ability to obtain additional
funding for operations and to complete the development and
commercialisation 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:
- BRUKINSA Australia Product Information. Available at
https://www.beigene.com.au/PDF/BRUKINSAAUPI.pdf. Accessed October
2021.
-
https://www.lymphoma.org.au/types-of-lymphoma/non-hodgkin-lymphoma.
Accessed August 2021.
-
https://www.lls.org/sites/default/files/2021-07/FS20_Waldenstrom_FactSheet_2021.pdf.
Accessed August 2021.
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BeiGene Corporate Contacts Investor Contact
Gabrielle Zhou +86 10-5895-8058 ir@beigene.com Media Contact
Emily Collins +1 201-201-4570 media@beigene.com Australia Media
Contact Jenny Westdorp jenny@healthythinkinggroup.com +61 0413
334 425
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