First completed regulatory submission for a
PD-1 immune checkpoint inhibitor in lung cancer
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the
European Medicines Agency (EMA) has validated for review the
Marketing Authorization Application (MAA) for nivolumab in
non-small cell lung cancer (NSCLC) – the first completed regulatory
submission for a PD-1 immune checkpoint inhibitor in this tumor
type.
“Lung cancer is the leading cause of cancer death worldwide, and
there remains a significant need for effective treatment options
for patients with this disease,” said Michael Giordano, M.D.,
senior vice president, Head of Oncology Development, Bristol-Myers
Squibb. “We are pleased to have two applications for nivolumab now
under review in the E.U., and look forward to continued
collaboration with health authorities around the world as we work
to bring nivolumab to patients.”
The MAA submitted to the EMA in lung cancer is based on data
from the Phase 2 study of nivolumab in third-line pre-treated
squamous cell NSCLC (Study -063).
In addition to the MAA for lung cancer in the E.U., the company
previously announced that it has initiated a rolling submission
with the FDA for Opdivo in third-line pre-treated squamous cell
NSCLC and expects to complete the submission by year-end.
About Opdivo (nivolumab)
Cancer cells may exploit “regulatory” pathways, such as
checkpoint pathways, to hide from the immune system and shield the
tumor from immune attack. Opdivo 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.
Bristol-Myers Squibb has a broad, global development program to
study Opdivo 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 NSCLC,
melanoma, renal cell carcinoma (RCC), head and neck cancer,
glioblastoma and non-Hodgkin lymphoma.
In 2013, the FDA granted Fast Track designation for Opdivo in
NSCLC, melanoma and RCC. In April 2014, the company initiated a
rolling submission with the FDA for Opdivo in third-line
pre-treated squamous cell NSCLC and expects to complete the
submission by year-end. The FDA granted its first Breakthrough
Therapy Designation for Opdivo in May 2014 for the treatment of
patients with Hodgkin lymphoma after failure of autologous stem
cell transplant and brentuximab. On July 4, Ono Pharmaceutical
Co. announced that Opdivo received manufacturing and marketing
approval in Japan for the treatment of patients with unresectable
melanoma, making Opdivo the first PD-1 immune checkpoint inhibitor
to receive regulatory approval anywhere in the world. On September
26, Bristol-Myers Squibb announced that the FDA accepted for
priority review the BLA for previously treated advanced melanoma,
and the Prescription Drug User Fee Act (PDUFA) goal date for a
decision is March 30, 2015. The FDA also granted Opdivo
Breakthrough Therapy status for this indication. In the E.U., the
EMA has validated for review the MAA for Opdivo in advanced
melanoma. The application has also been granted accelerated
assessment by the EMA’s Committee for Medicinal Products for Human
Use (CHMP).
Bristol-Myers Squibb has proposed the
name Opdivo (pronounced op-dee-voh), which, if approved
by health authorities, will serve as the trademark for
nivolumab.
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally,
resulting in more than 1.5 million deaths each year according the
World Health Organization. NSCLC is one of the most common types of
the disease and accounts for approximately 85 percent of cases.
Survival rates vary depending on the stage and type of the cancer
when it is diagnosed. Globally, the five-year survival rate for
Stage I NSCLC is between 47 and 50 percent; for Stage IV NSCLC, the
five-year survival rate drops to two percent.
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 the innovative field of 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
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 the Bristol-Myers Squibb and Ono
Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono
Pharmaceutical, Bristol-Myers Squibb expanded its territorial
rights to develop and commercialize Opdivo globally except in
Japan, South Korea and Taiwan, where Ono had retained all rights to
the compound at the time. On July 23, 2014, Bristol-Myers Squibb
and Ono Pharmaceutical further expanded the companies’ strategic
collaboration agreement to jointly develop and commercialize
multiple immunotherapies – as single agents and combination
regiments – for patients with cancer in Japan, South Korea and
Taiwan.
About Bristol-Myers
Squibb
Bristol-Myers Squibb is a global pharmaceutical 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 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 Opdivo will receive regulatory approval in the E.U. 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.
Bristol-Myers Squibb CompanyMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorChrissy Trank,
609-252-3418christina.trank@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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