- Fast Track milestone for avelumab
builds upon recent Orphan Drug designation in this aggressive skin
cancer
- Fast Track designation highlights
the serious, unmet medical need that exists for patients with this
disease
Merck KGaA, Darmstadt, Germany, and Pfizer today announced that
the US Food and Drug Administration (FDA) has granted avelumab*, an
investigational fully human anti-PD-L1 IgG1 monoclonal antibody,
Fast Track designation for the treatment of metastatic Merkel cell
carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 This
announcement builds on the recent FDA Orphan Drug designation that
was granted for avelumab on September 21, 2015 for the treatment of
MCC. The Fast Track designation is designed to facilitate the
development, and expedite the review, of drugs to treat serious
conditions and address an unmet medical need.
This Smart News Release features multimedia.
View the full release here:
http://www.businesswire.com/news/home/20151007005668/en/
“We are pleased that the FDA continues to acknowledge the
current high unmet needs for patients with metastatic Merkel cell
carcinoma through these recent regulatory designations for
avelumab,” said Dr. Luciano Rossetti, Global Head of Research &
Development of the biopharmaceutical business of Merck KGaA,
Darmstadt, Germany. “We look forward to working closely with the
FDA on an expedited review process for avelumab, and we hope to be
able to provide a potential new treatment option for patients with
this difficult-to-treat cancer in the future.”
“We look forward to working with our partners at Merck KGaA,
Darmstadt, Germany, on the development of avelumab in patients with
relapsed and refractory Merkel cell carcinoma,” said Dr. Mace
Rothenberg, Senior Vice President of Clinical Development and
Medical Affairs and Chief Medical Officer for Pfizer Oncology.
“Fast Track designation will enable us to coordinate these efforts
more closely with the FDA.”
The designation relates to the clinical development program for
avelumab in metastatic MCC, which includes the Phase II study,
JAVELIN Merkel 200, to assess the safety and efficacy of avelumab
in patients with metastatic MCC who have progressed after at least
one prior chemotherapy regimen. In this study, the primary endpoint
is objective response rate, and secondary endpoints include
duration of response, progression-free survival, overall survival
and safety. The study, which exceeded its expected enrollment of 84
patients with 88 patients enrolled, is being conducted in sites
across Asia Pacific, Australia, Europe and North America.
The clinical development program for avelumab now includes more
than 1,000 patients who have been treated across more than 15 tumor
types, including breast cancer, gastric/gastroesophageal cancer,
head and neck cancer, MCC, mesothelioma, melanoma, non-small cell
lung cancer, ovarian cancer, renal cell carcinoma and urothelial
(e.g. bladder) cancer.
About the FDA Designations
FDA’s granting of the Fast Track and Orphan Drug designations
for metastatic MCC does not alter the standard regulatory
requirement to establish the safety and effectiveness of a drug
through adequate and well-controlled studies to support
approval.
Fast Track is designed to facilitate the development, and
expedite the review, of drugs to treat serious conditions and
address an unmet medical need. Once a drug receives Fast Track
designation, early and frequent communication between the FDA and a
drug company is encouraged throughout the entire drug development
and review process. The frequency of communication can help resolve
questions and issues quickly, often leading to earlier drug
approval and patient access to important new therapies. Fast Track
designated products are eligible for accelerated approval and
priority review, if relevant criteria are met, and rolling FDA
review of marketing applications.
FDA Orphan Drug designation is granted to drugs intended to
treat rare diseases or disorders that affect fewer than 200,000
people in the US, or those that affect more than 200,000 people,
but are unlikely to recover the costs of developing and marketing
the drug.
*Avelumab is the proposed International Nonproprietary Name for
the anti-PD–L1 monoclonal antibody (MSB0010718C). Avelumab is under
clinical investigation and has not been proven to be safe and
effective. There is no guarantee that avelumab will be approved in
the sought-after indication by any health authority worldwide.
References
1. Hughes MP et al. Merkel cell carcinoma: epidemiology, target,
and therapy. Curr Dermatol Rep 2014;3:46–53.2. Kaae J et al. Merkel
cell carcinoma: incidence, mortality, and risk of other cancers. J
Natl Cancer Inst 2010;102(11):793–801.
Avelumab is currently under clinical investigation and has not
been approved for use in the US, EU, Canada, or elsewhere. All
investigational products have not yet been proven to be either safe
or effective and any claims of safety and effectiveness can be made
only after regulatory review of the data and approval of the
labeled claims.
About Merkel Cell Carcinoma (MCC)
MCC is a rare and aggressive disease in which cancer cells form
in the top layer of the skin, close to nerve endings. MCC, which is
also known as neuroendocrine carcinoma of the skin or trabecular
cancer, often starts in those areas of skin that are most often
exposed to the sun, including the head and neck, arms, legs, and
trunk. Risk factors for MCC include sun exposure and having a weak
immune system (i.e., solid organ transplant recipients, people with
HIV/AIDS and people with other cancers, such as chronic lymphocytic
leukemia, are at higher risk). Caucasian males over age 50 are at
increased risk. MCC tends to metastasize at an early stage,
spreading initially to nearby lymph nodes, and then potentially to
more distant areas in the body, including other lymph nodes or
areas of skin, lungs, brain, bones or other organs. Current
treatment options for MCC include surgery, radiation and
chemotherapy. Treatment for metastatic or Stage IV MCC is generally
palliative.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational fully
human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1
interactions, avelumab is thought to potentially enable the
activation of T cells and the adaptive immune system. By retaining
a native Fc-region, avelumab is thought to 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.
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 companies will
collaborate on up to 20 high-priority immuno-oncology clinical
development programs, including combination trials, many of which
are expected to commence in 2015.
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
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. To learn more, please visit us at
www.pfizer.com.
Merck KGaA, Darmstadt, Germany
Merck KGaA of Darmstadt, Germany, is a leading company for
innovative and top-quality high-tech products in healthcare, life
science and performance materials. The company has six businesses –
Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars,
Life Science and Performance Materials – and generated sales of €
11.3 billion in 2014. Around 39,000 employees work in 66 countries
to improve the quality of life for patients, to foster the success
of customers and to help meet global challenges. Merck KGaA,
Darmstadt, Germany, is the world’s oldest pharmaceutical and
chemical company – since 1668, the company has stood for
innovation, business success and responsible entrepreneurship.
Holding an approximately 70% interest, the founding family remains
the majority owner of the company to this day. Merck KGaA,
Darmstadt, Germany holds the global rights to the Merck name and
brand. The only exceptions are Canada and the United States, where
the company operates as EMD Serono, EMD Millipore and EMD
Performance Materials.
All Merck KGaA, Darmstadt, Germany, press releases are
distributed by e-mail at the same time they become available on the
EMD Group Website. In case you are a resident of the US or Canada,
please go to http://www.emdgroup.com/subscribe to register again
for your online subscription of this service as our newly
introduced geo-targeting requires new links in the email. You may
later change your selection or discontinue this service.
Pfizer Disclosure Notice
The information contained in this release is as of October 7,
2015. 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 MCC, 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 as well as the possibility of
unfavorable study results; risks associated with interim data,
including the risk that the final results of the Phase I study for
avelumab and/or additional clinical trials may be different from
(including less favorable than) the interim data results and may
not support further clinical development; 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 any jurisdictions for any potential indications for
avelumab, combination therapies or other product candidates;
whether and when any such 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, 2014, 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 SEC and available at www.sec.gov and
www.pfizer.com.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151007005668/en/
Merck KGaA,Media: Gangolf Schrimpf, +49 6151 72
9591Investor Relations: +49 6151 72 3321orPfizer, Inc, New York,
USAMedia: Sally Beatty, +1 212 733 6566Investor Relations: Ryan
Crowe, +1 212 733 8160
Pfizer (NYSE:PFE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Pfizer (NYSE:PFE)
Historical Stock Chart
From Apr 2023 to Apr 2024