Bristol-Myers Squibb Company (NYSE:BMY) today announced that,
following discussions with the U.S. Food and Drug Administration
(FDA), the company is planning a third quarter submission of a
Biologics Licensing Application (BLA) for Opdivo® (nivolumab) for
previously treated advanced melanoma. This will mark the second
tumor type for which Bristol-Myers Squibb has a regulatory
submission underway for Opdivo in the U.S.
“We continue to collaborate closely with the FDA on Opdivo and
the planned submission in advanced melanoma represents an important
step forward in our company’s commitment to deliver innovative
treatment options for patients with cancer,” said Michael Giordano,
MD, Head of Oncology Development, Bristol-Myers Squibb.
The advanced melanoma BLA is based on data from Checkmate -037,
a multinational, multicenter, randomized open-label Phase 3 trial
evaluating Opdivo compared to dacarbazine (DTIC) or
carboplatin/paclitaxel in patients with unresectable or metastatic
melanoma who have been previously treated with Yervoy® (ipilimumab)
and, if BRAF-mutation positive, a BRAF inhibitor regimen.
Bristol-Myers Squibb has proposed the name Opdivo (pronounced
op-dee-voh), which, if approved by health authorities, will serve
as the trade name for nivolumab.
About Opdivo
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.
We are investigating whether by blocking this pathway, Opdivo 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 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 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
Opdivo® (nivolumab) 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 Opdivo
Breakthrough Therapy Designation in May 2014 for the treatment of
patients with Hodgkin lymphoma after failure of autologous stem
cell transplant and brentuximab. On July 4th, 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.
About Advanced Melanoma
Melanoma is a form of skin cancer characterized by the
uncontrolled growth of pigment-producing cells (melanocytes)
located in the skin. Metastatic melanoma is the deadliest form of
the disease, and occurs when cancer spreads beyond the surface of
the skin to the other organs, such as the lymph nodes, lungs, brain
or other areas of the body. The incidence of melanoma has been
increasing for at least 30 years. In 2012, an estimated 232,130
melanoma cases were diagnosed globally. Melanoma is mostly curable
when treated in its early stages. However, in its late stages, the
average survival rate has historically been just six months with a
one-year mortality rate of 75 percent, making it one of the most
aggressive forms of cancer.
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
Through a collaboration agreement with Ono Pharmaceutical in
2011, Bristol-Myers Squibb expanded its territorial rights to
develop and commercialize Opdivo® (nivolumab) globally
except in Japan, Korea and Taiwan, where Ono has retained all
rights to the compound.
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 U.S. 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 SquibbMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorInvestors:Ranya Dajani,
609-252-5330ranya.dajani@bms.comorRyan Asay,
609-252-5020ryan.asay@bms.com
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