This acceptance for review marks the first in the U.S. for a
SLAMF7-directed immunostimulatory antibody
PRINCETON, N.J.--(BUSINESS WIRE)--
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
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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.
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Source: Bristol-Myers Squibb Company