BeiGene’s BGB-16673 Receives U.S. FDA Fast Track Designation for CLL/SLL
August 26 2024 - 5:00AM
Business Wire
Designation supported by promising safety and
efficacy data from Phase 1/2 study in heavily pretreated patients
with relapsed/refractory (R/R) chronic lymphocytic leukemia or
small lymphocytic lymphoma (CLL/SLL)
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology company, today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track Designation to
BGB-16673, an orally available investigational Bruton’s tyrosine
kinase (BTK) targeting chimeric degradation activation compound
(CDAC), for adult patients with relapsed or refractory (R/R)
chronic lymphocytic leukemia or small lymphocytic lymphoma
(CLL/SLL) who have been previously treated with at least two prior
lines of therapy, including BTK inhibitor (BTKi) and B-cell
lymphoma 2 (BCL2) inhibitor.
The FDA’s Fast track designation is aimed to facilitate the
development and expedite the review of drugs to treat serious
conditions and fill an unmet medical need. The purpose is to get
important new drugs to patients earlier.
“When disease progression for patients on BTK inhibitors occurs,
there is a need for BTK-targeting agents with a different mode of
action given the centrality of this pathway in CLL/SLL. BTK-protein
degradation with our BTK CDAC (BGB-16673) may address this unmet
need,” said Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer,
Hematology. “The FDA’s Fast Track Designation supports our goal of
efficiently developing BGB-16673 for these patients, the first
investigational drug from our CDAC platform. We believe BGB-16673
strengthens our hematology leadership and complements BRUKINSA
(zanubrutinib), the backbone for our investigational hematology
pipeline. BGB-16673 is the most advanced BTK degrader in the clinic
and is well-suited to become an important therapy for patients
progressing after BTKi who have limited options.”
The designation was requested based on the potential for
BGB-16673 to address an unmet medical need for patients CLL/SLL
whose disease has progressed. Data from ongoing first-in-human
Phase 1/2 (NCT05006716) presented at the European Hematology
Association 2024 Hybrid Congress in June highlighted the tolerable
safety and promising efficacy in heavily pretreated patients with
R/R CLL/SLL. More than 300 patients have been treated to date in 15
countries across the BGB-16673 global clinical development
program.
About Chronic Lymphocytic Leukemia
A life-threatening cancer of adults, chronic lymphocytic
leukemia (CLL) is a type of mature B-cell malignancy in which
abnormal leukemic B lymphocytes (a type of white blood cells) arise
from the bone marrow and flood peripheral blood, bone marrow, and
lymphoid tissues.1,2 CLL is the most common type of leukemia in
adults, accounting for about one-third of new cases of leukemia.2,3
Approximately 20,700 new cases of CLL will be diagnosed in the U.S.
in 2024.3
About BGB-16673
BGB-16673 is an orally available Bruton’s tyrosine kinase (BTK)
targeting chimeric degradation activation compound (CDAC) designed
to induce degradation of wildtype and multiple mutant forms of BTK,
including those that commonly confer resistance to BTK inhibitors
in patients who experience progressive disease.
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. To learn more about
BeiGene, please visit www.beigene.com and follow us on LinkedIn, X
(formerly known as Twitter), Facebook and Instagram.
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 ability of BGB-16673 to fulfill an unmet medical need;
BeiGene’s ability to efficiently develop BGB-16673; whether
BGB-16673 becomes an important therapy for patients progressing
after BTKi who have limited options; 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 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.
To access BeiGene media resources, please visit our News
& Media site.
1 National Cancer Institute. Chronic Lymphocytic Leukemia
Treatment (PDQ)–Patient Version. Accessed November 2023.
https://www.cancer.gov/types/leukemia/hp/cll-treatment-pdq. 2
American Cancer Society. What is Chronic Lymphocytic Leukemia?
Updated May 10, 2018. Accessed November 2023.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/what-is-cll.html.
3 American Cancer Society. Key Statistics for Chronic Lymphocytic
Leukemia. Updated July 1, 2024. Accessed August 2024.
https://www.cancer.org/cancer/types/chronic-lymphocytic-leukemia/about/key-statistics.html.
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Investors: Liza Heapes +1 857-302-5663 ir@beigene.com
Media: Kim Bencker +1 610-256-8932 media@beigene.com
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