- FDA accepts for priority review the
Biologics License Application for previously treated advanced
melanoma, based on data from first Phase 3 randomized trial of a
PD-1 immune checkpoint inhibitor; agency grants second breakthrough
therapy designation for Opdivo
- European Medicines Agency validates
the marketing authorization application for advanced melanoma;
accelerated assessment also granted
Bristol-Myers Squibb Company (NYSE:BMY) today announced multiple
regulatory milestones for Opdivo (nivolumab), an investigational
PD-1 immune checkpoint inhibitor, in the U.S. and European Union.
In the U.S., the Food and Drug Administration (FDA) has accepted
for priority review the Biologics License Application (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 European Union, the European Medicines Agency
(EMA) has validated for review the Marketing Authorization
Application (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).
“The filing acceptance and validation of our Opdivo applications
by the FDA and EMA represent significant steps forward in our
commitment to delivering innovative immuno-oncology treatments to
patients with cancer around the world,” said Michael Giordano, MD,
senior vice president, Head of Oncology Development, Bristol-Myers
Squibb. “Additionally, the Breakthrough Therapy Designation and the
accelerated assessment for advanced melanoma underscore our focus
on developing treatments for diseases in which a significant unmet
medical need remains.”
About the U.S. Biologics License
Application
The U.S. BLA is based on data from CheckMate -037, a
multinational, multicenter, randomized open-label Phase 3 trial
evaluating Opdivo compared to the physician’s choice of either
dacarbazine (DTIC) or carboplatin/paclitaxel in patients with
unresectable or metastatic melanoma who have been previously
treated with Yervoy and, if BRAF-mutation positive, a BRAF
inhibitor. Interim data from CheckMate -037 will be highlighted at
an ESMO 2014 Congress press briefing on September 29 in the morning
and presented during the Presidential Symposium at 4 p.m. CEST
(Abstract #LBA3_PR).
In the U.S., priority review status is granted for applications
for drugs that treat a serious condition and, if approved, would be
a significant improvement in the safety or effectiveness of the
treatment, diagnosis, or prevention of serious conditions when
compared to standard applications. Breakthrough Therapy
Designation, according to the FDA, is intended to expedite the
development and review of drugs for serious or life-threatening
conditions. The criteria for this designation require preliminary
clinical evidence that demonstrates that the drug may have
substantial improvement on at least one clinically significant
endpoint over available therapy.
About the E.U. Marketing Authorization
Applications
The MAA submitted to the EMA in advanced melanoma is also
supported by data from CheckMate -037. Accelerated assessment
procedure may be requested for medicinal products of major interest
from the point of view of public health and, in particular, from
the point of view of therapeutic innovation. The acceptance of
accelerated assessment by the CHMP could shorten the review time of
Opdivo in advanced melanoma by approximately two months.
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.
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 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.
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 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
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 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.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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