Bristol-Myers
Squibb Company (NYSE:BMY) today announced that the U.S. Food and
Drug Administration (FDA) has granted the investigational PD-1 immune
checkpoint inhibitor nivolumab Breakthrough Therapy Designation for the
treatment of patients with Hodgkin lymphoma (HL) after failure of
autologous stem cell transplant and brentuximab. The designation is
based on data from a cohort of patients with HL in the company’s ongoing
Phase 1b study of relapsed and refractory hematological malignancies.
According to the FDA, Breakthrough Therapy Designation is intended to
expedite the development and review of drugs for serious or
life-threatening conditions. The criteria for Breakthrough Therapy
Designation require preliminary clinical evidence that demonstrates the
drug may have substantial improvement on at least one clinically
significant endpoint over available therapy.
“The Breakthrough Therapy Designation granted by the FDA for nivolumab
continues to support the development of innovative approaches designed
to advance how cancer is treated,” said Michael Giordano, senior vice
president, Head of Development, Oncology & Immunosciences. “It is our
goal to change the way patients live with cancer, especially in areas of
high unmet medical need like Hodgkin lymphoma where patients may be
underserved by currently available treatment options.”
About Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer of the
lymphatic system, which originates in the white blood cells. HL is one
of two main types of lymphomas. The five-year survival rate for advanced
HL is approximately 65 percent in the U.S. If patients with relapsed and
refractory HL progress within one year after receiving autologous stem
cell transplant (the standard of care), the median survival is just 1.3
years after progression. The median age of diagnosis is 38 in the U.S.
This year, more than 9,100 new cases are estimated to be diagnosed with
more than 1,100 deaths expected.
About Nivolumab
Nivolumab is an investigational, fully-human PD-1 immune checkpoint
inhibitor that binds to the checkpoint receptor PD-1 (programmed
death-1) expressed on activated T-cells. We are investigating whether by
blocking this pathway, nivolumab would enable the immune system to
resume its ability to recognize, attack and destroy cancer cells.
Bristol-Myers Squibb has a broad, global development program to study
nivolumab in multiple tumor types consisting of more than 35 trials – as
monotherapy or in combination with other therapies – in which more than
7,000 patients have been enrolled worldwide. Among these are several
potentially registrational trials in non-small cell lung cancer (NSCLC),
melanoma, renal cell carcinoma (RCC), head and neck cancer, glioblastoma
and non-Hodgkin lymphoma. In 2013, the FDA granted Fast Track
designation for nivolumab in NSCLC, melanoma and RCC.
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 advances in a rapidly evolving
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. This includes conducting research
on the potential of combining immuno-oncology agents that target
different and complementary 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.
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.
Bristol-Myers Squibb Forward-Looking Statements
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 the compound mentioned
in this release will move into full product development, that the
clinical trials of the compound mentioned in this release will move into
full product development, that the clinical trials of this compound will
support regulatory filings, or that the compound will receive regulatory
approval 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, 2013 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.
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