Bristol-Myers
Squibb Company (NYSE:BMS) 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.
Copyright Business Wire 2014