ROCKLAND, Massachusetts and
NEW YORK, February 28, 2017 /PRNewswire/ --
- Second Biologics License Application accepted by the
FDA for avelumab
- Prognosis for urothelial carcinoma is currently poor,
particularly when the disease has metastasized
EMD Serono, the biopharmaceutical business of Merck KGaA,
Darmstadt, Germany, in the US and
Canada, and Pfizer Inc. today
announced that the US Food and Drug Administration (FDA) has
accepted for Priority Review EMD Serono's Biologics License
Application (BLA) for avelumab* as a treatment for patients with
locally advanced or metastatic urothelial carcinoma (mUC) with
disease progression on or after platinum-based therapy. The FDA has
set a Prescription Drug User Fee Act (PDUFA) target action date of
August 27, 2017, for avelumab in this
indication.
"Taken together with last year's filing for metastatic Merkel
cell carcinoma, this BLA acceptance confirms our rapid and
continued progress in the clinical development of avelumab," said
Luciano Rossetti, M.D., Executive
Vice President, Global Head of Research & Development at the
biopharma business of Merck KGaA, Darmstadt, Germany. "We continue to evaluate avelumab in
cancers that have limited or suboptimal treatment choices, such as
metastatic or locally advanced urothelial carcinoma, to hopefully
be able to provide patients with new treatment options for fighting
their disease."
Despite advances in the treatment of UC, the prognosis for
patients remains poor, particularly when the disease has
metastasized. Bladder cancer makes up approximately 90% of
urothelial cancers and is the sixth most common cancer in the
US.[1],[2]
"Advanced urothelial carcinoma remains a difficult-to-treat
tumor, which is why we are developing a comprehensive clinical
development program that involves Phase I and III trials designed
to address this challenge," said Chris
Boshoff, M.D., Ph.D., Senior Vice President and Head of
Immuno-oncology, Early Development and Translational Oncology,
Pfizer Global Product Development. "We're continuing to accelerate
our urothelial carcinoma development program and look forward to
continuing our dialogue with the FDA."
Avelumab is an investigational, fully human anti-PD-L1 antibody.
The FDA's Priority Review status reduces the review time from 10
months to a goal of six months from the day of filing acceptance
and is given to drugs that may offer major advances in treatment or
may provide a treatment where no adequate therapy exists. In
November 2016, the FDA accepted, and
granted Priority Review status to, the BLA for avelumab for the
treatment of patients with metastatic Merkel cell carcinoma.
The international clinical development program for avelumab,
known as JAVELIN, involves at least 30 clinical programs, including
nine Phase III trials, and more than 4,000 patients evaluated
across more than 15 tumor types. In December
2015, Merck KGaA, Darmstadt, Germany, and Pfizer announced the initiation
of a Phase III study (JAVELIN Bladder 100) of avelumab in the
first-line setting as a maintenance treatment in patients with
locally advanced or metastatic UC. This trial is currently
enrolling patients.
*Avelumab is not approved for any indication in any market. This
marks the second acceptance of an application by the FDA to review
the investigational product, avelumab.
References
- National Comprehensive Cancer Network. NCCN Guidelines Version
1.2017 Updates. Bladder Cancer. Available from:
https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf.
Last Accessed: February 2017.
- Siegel RL, et al. Cancer Statistics, 2017. CA Cancer J Clin
2017;67:7-30. Available from:
https://www.ncbi.nlm.nih.gov/pubmed/28055103. Last Accessed:
February 2017.
- American Cancer Society. Key Statistics for Bladder Cancer.
Available from:
https://www.cancer.org/cancer/bladder-cancer/about/key-statistics.html.
Last Accessed: February 2017.
About Metastatic Urothelial Carcinoma
Urothelial Carcinoma includes several tumors originating from
the cells lining the bladder, renal pelvis and urethra. While
cancers outside of the bladder are relatively uncommon, accounting
for an estimated 10% of cases, bladder cancer represents 90% of
urothelial cancers and is the ninth most common cancer
globally.[1],[3]
Worldwide, approximately 400,000 new cases of bladder cancer are
diagnosed and 150,000 deaths are attributed to this disease each
year.[3] The incidence and
mortality of bladder cancer have remained unchanged over the past
25 years.[3]
About Avelumab
Avelumab is a fully human antibody specific for a protein found
on tumor cells called PD-L1, or programmed death ligand-1. By
inhibiting PD-L1 interactions, avelumab is thought to enable the
activation of T-cells and the adaptive immune system. By retaining
a native Fc-region, avelumab is thought to potentially engage the
innate immune system and induce antibody-dependent cell-mediated
cytotoxicity (ADCC). In November
2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic
alliance to co-develop and co-commercialize avelumab. Common
adverse reactions include fatigue, musculoskeletal pain, diarrhea,
nausea peripheral edema, decreased appetite, and
rash. Immune-mediated adverse reactions have also been
reported.
Alliance between Merck KGaA, Darmstadt,
Germany, and Pfizer
Inc., New York, US
Immuno-oncology is a top priority for Merck KGaA, Darmstadt,
Germany, and Pfizer Inc. The
global strategic alliance between Merck KGaA, Darmstadt,
Germany, and Pfizer Inc.,
New York, US, enables the
companies to benefit from each other's strengths and capabilities
and further explore the therapeutic potential of avelumab, an
investigational anti-PD-L1 antibody initially discovered and
developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will
jointly develop and commercialize avelumab and advance Pfizer's
PD-1 antibody. The alliance is focused on developing high-priority
international clinical programs to investigate avelumab as a
monotherapy, as well as in combination regimens, and is striving to
find new ways to treat cancer.
About EMD Serono, Inc.
EMD Serono is the biopharmaceutical business of Merck KGaA,
Darmstadt, Germany - a leading
science and technology company - in the US and Canada focused exclusively on specialty care.
For more than 40 years, the business has integrated cutting-edge
science, innovative products and industry-leading patient support
and access programs. EMD Serono has deep expertise in neurology,
fertility and endocrinology, as well as a robust pipeline of
potential therapies in oncology, immuno-oncology and immunology as
R&D focus areas. Today, the business has 1,200 employees around
the country with commercial, clinical and research operations based
in the company's home state of Massachusetts. http://www.emdserono.com
About Merck KGaA, Darmstadt, Germany
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Merck KGaA, Darmstadt, Germany
is a leading science and technology company in healthcare, life
science and performance materials. Around 50,000 employees work to
further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2015, Merck
KGaA, Darmstadt, Germany,
generated sales of € 12.85 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical
and chemical company. The founding family remains the majority
owner of the publicly listed corporate group. Merck KGaA,
Darmstadt, Germany operates as EMD
Serono, MilliporeSigma and EMD Performance Materials in
the United States and Canada.
Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of healthcare
products. Our global portfolio includes medicines and vaccines, as
well as many of the world's best-known consumer healthcare
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
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expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
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Pfizer Disclosure Notice
The information contained in this release is as of February 28, 2017. Pfizer assumes no obligation
to update forward-looking statements contained in this release as
the result of new information or future events or developments.
This release contains forward-looking information about avelumab
(MSB0010718C), including a potential indication for avelumab for
the treatment of metastatic urothelial carcinoma (the "Potential
Indication"), Pfizer's and Merck, KGaA, Darmstadt, Germany's immuno-oncology alliance involving
anti-PD-L1 and anti-PD-1 therapies, and clinical development plans,
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the
ability to meet anticipated clinical study commencement and
completion dates and regulatory submission dates, as well as the
possibility of unfavorable study results; risks associated with
interim data; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate, regulatory authorities may not share our views and may
require additional data or may deny approval altogether; whether
and when drug applications may be filed in other jurisdictions for
the Potential Indication and whether and when drug applications may
be filed in any jurisdictions for any other potential indications
for avelumab, combination therapies or other product candidates;
whether and when the BLA for the Potential Indication, the BLA and
EU marketing authorization application for avelumab for the
treatment of metastatic Merkel cell carcinoma or any such other
applications may be approved by regulatory authorities, which will
depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of avelumab, combination
therapies or other product candidates; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer's Annual Report on Form 10-K for the fiscal year ended
December 31, 2015, and in its
subsequent reports on Form 10-Q, including in the sections thereof
captioned "Risk Factors" and "Forward-Looking Information and
Factors That May Affect Future Results", as well as in its
subsequent reports on Form 8-K, all of which are filed with the
U.S. Securities and Exchange Commission and available at
http://www.sec.gov and http://www.pfizer.com.
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SOURCE EMD Serono and Pfizer