This acceptance for review marks the first
in the U.S. for a SLAMF7-directed immunostimulatory
antibody
Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie
(NYSE:ABBV) today announced the U.S. Food and Drug Administration
(FDA) has accepted for priority review the Biologics License
Application (BLA) for Empliciti (elotuzumab), an investigational
Signaling Lymphocyte Activation Molecule (SLAMF7)-directed
immunostimulatory antibody, for the treatment of multiple myeloma
as combination therapy in patients who have received one or more
prior therapies. Empliciti was previously granted Breakthrough
Therapy Designation, which according to the FDA, is intended to
expedite the development and review of drugs for serious or
life-threatening conditions. The European Medicines Agency (EMA)
also recently validated for review the Marketing Authorization
Application for Empliciti, granting it accelerated assessment.
Bristol-Myers Squibb has proposed the name Empliciti which,
if approved by health authorities, will serve as the brand name for
elotuzumab.
“Bristol-Myers Squibb is delighted by the approach both agencies
have taken to review the Empliciti applications as it underscores
the unmet medical need in the treatment of multiple myeloma and the
role Immuno-Oncology may play,” said Michael Giordano, M.D., senior
vice president, Head of Oncology Development, Bristol-Myers Squibb.
“The acceptance of our applications by the FDA and EMA brings
Bristol-Myers Squibb’s Immuno-Oncology science a step closer to
helping patients with hematologic malignancies.”
The filing acceptance is primarily supported by data from the
ELOQUENT-2 trial, a Phase 3, randomized, open-label study, which
evaluated Empliciti in combination with lenalidomide and
dexamethasone versus lenalidomide and dexamethasone alone. The
results of this trial were published in The New England Journal of
Medicine on June 2. Additionally, the filing was supported by data
from study CA204-009, a Phase 2, randomized, open-label study which
evaluated Empliciti with bortezomib and dexamethasone versus
bortezomib and dexamethasone alone. These Phase 2 results were
presented in an oral session (Abstract #S103) at the 20th Congress
of the European Hematology Association (EHA).
“AbbVie is encouraged by the FDA’s decision to award priority
review to this application,” said Gary Gordon, M.D., vice
president, oncology clinical development, AbbVie. “AbbVie is
committed to the development of novel treatment options for people
affected by cancer.”
About Empliciti
Bristol-Myers Squibb has proposed the name Empliciti which,
if approved by health authorities, will serve as the brand name for
elotuzumab. Elotuzumab is an investigational immunostimulatory
antibody targeted against SLAMF7, a cell-surface glycoprotein that
is highly and uniformly expressed on myeloma cells and Natural
Killer (NK) cells, but is not detected on normal solid tissues or
on hematopoietic stem cells. The safety and efficacy of elotuzumab
have not been evaluated by the FDA or any other health
authority.
Bristol-Myers Squibb and AbbVie are co-developing elotuzumab,
with Bristol-Myers Squibb solely responsible for commercial
activities.
About Multiple Myeloma
Multiple myeloma is a hematologic, or blood, cancer that
develops in the bone marrow. It occurs when a plasma cell, a type
of cell in the soft center of bone marrow, becomes cancerous and
multiplies uncontrollably. Despite advances in multiple myeloma
treatment over the last decade, it remains a largely incurable
disease with only 45% of patients surviving five years after
diagnosis. A common characteristic for many patients is that they
experience a cycle of remission and relapse, in which they stop
treatment for a short time, but eventually return to a treatment
shortly after. Following relapse, less than 20% of patients are
alive after five years. It is estimated that annually more than
114,200 new cases of multiple myeloma are diagnosed globally and
annually more than 79,000 people die from the disease globally.
Immuno-Oncology at Bristol-Myers
Squibb
Surgery, radiation, cytotoxic or targeted therapies have
represented the mainstay of cancer treatment over the last several
decades, but long-term survival and a positive quality of life have
remained elusive for many patients with advanced disease.
To address this unmet medical need, Bristol-Myers Squibb is
leading research in an innovative field of cancer research and
treatment known as Immuno-Oncology, which involves agents whose
primary mechanism is to work directly with the body’s immune system
to fight cancer. The company is exploring a variety of compounds
and immunotherapeutic approaches for patients with different types
of cancer, including researching the potential of combining
Immuno-Oncology agents that target different pathways in the
treatment of cancer.
Bristol-Myers Squibb is committed to advancing the science of
Immuno-Oncology, with the goal of changing survival expectations
and the way patients live with cancer.
Oncology at AbbVie
AbbVie's oncology research is focused on the discovery and
development of targeted therapies that work against the processes
cancers need to survive. By investing in new technologies and
approaches, AbbVie is breaking ground in some of the most
widespread and difficult-to-treat cancers, including glioblastoma
multiforme, multiple myeloma and chronic lymphocytic leukemia.
AbbVie's oncology pipeline includes multiple new molecules in
clinical trials being studied in more than 15 different cancers and
tumor types. For more information on AbbVie Oncology, please visit
http://oncology.abbvie.com.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit www.bms.com or follow
us on Twitter at http://twitter.com/bmsnews.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company
formed in 2013 following separation from Abbott Laboratories. The
company’s mission is to use its expertise, dedicated people and
unique approach to innovation to develop and market advanced
therapies that address some of the world’s most complex and serious
diseases. Together with its wholly-owned subsidiary, Pharmacyclics,
AbbVie employs more than 28,000 people worldwide and markets
medicines in more than 170 countries. For further information on
the company and its people, portfolio and commitments, please visit
www.abbvie.com. Follow @abbvie on Twitter or view careers on our
Facebook or LinkedIn page.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that elotuzumab will receive regulatory approval for one or more
indications or, if approved, that it will become a commercially
successful product. Forward-looking statements in this press
release should be evaluated together with the many uncertainties
that affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2014 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
AbbVie Forward-Looking Statements
Some statements in this news release may be forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995. The words "believe," "expect," "anticipate," "project"
and similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, the likelihood that
the transaction is consummated, the expected benefits of the
transaction, challenges to intellectual property, competition from
other products, difficulties inherent in the research and
development process, adverse litigation or government action, and
changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," in
AbbVie's 2014 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20150901005822/en/
Bristol-Myers Squibb CompanyMedia:Audrey Abernathy,
609-419-5375, cell: 919-605-4521
audrey.abernathy@bms.comorInvestors:Ranya Dajani,
609-252-5330, cell: 215-666-1515 ranya.dajani@bms.comBill
Szablewski, 609-252-5894, cell: 215-801-0906
william.szablewski@bms.com
AbbVie (NYSE:ABBV)
Historical Stock Chart
From Aug 2024 to Sep 2024
AbbVie (NYSE:ABBV)
Historical Stock Chart
From Sep 2023 to Sep 2024