FDA Approves Vectibix(TM) to Treat Patients with Metastatic Colorectal Cancer
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 27, 2006--Amgen
(NASDAQ:AMGN) today announced that the U.S. Food and Drug
Administration (FDA) has approved Vectibix(TM) (panitumumab) following
priority review. Vectibix is the first entirely human monoclonal
antibody for the treatment of patients with epidermal growth factor
receptor- (EGFr) expressing metastatic colorectal cancer after disease
progression on, or following fluoropyrimidine-, oxaliplatin-, and
irinotecan- containing chemotherapy regimens.
The FDA approval of Vectibix was based on a progression-free
survival endpoint. Vectibix is the first anti-EGFr antibody shown to
significantly improve progression-free survival in patients with
metastatic colorectal cancer. Currently no data are available that
demonstrate an improvement in disease-related symptoms or increased
survival with Vectibix. Vectibix can be conveniently administered
intravenously once every two weeks.
Vectibix is expected to be commercially available in early-to-mid
October and will be priced at approximately 20 percent less than the
other anti-EGFr antibody currently on the market.
"Vectibix is the first entirely human antibody for the treatment
of colorectal cancer to be approved by the FDA. It provides another
option for patients with metastatic colorectal cancer that have
progressed on all available chemotherapy regimens," said J. Randolph
Hecht, M.D., director of the UCLA Gastrointestinal Oncology Program
and clinical professor of Medicine, UCLA David Geffen School of
Medicine, Los Angeles. "In a large, randomized clinical trial,
Vectibix has been shown to delay progression of disease compared to
best supportive care."
Epidermal growth factor receptors are proteins that play an
important role in cancer cell signaling. Vectibix is an entirely human
IgG2 monoclonal antibody that binds with high affinity to EGF
receptors. The goal of developing entirely human monoclonal antibodies
is to offer effective targeted therapies with lessened risk of immune
response against these agents.
"Our goal is to fulfill the promise of biotechnology to improve
the way cancer is treated," said Willard Dere, M.D., chief medical
officer and senior vice president of Global Development at Amgen. "The
approval of Vectibix allows us to build on our strong foundation in
supportive care and move forward with our comprehensive approach to
helping patients in their fight against cancer."
"One out of 18 people in this country will develop colorectal
cancer in their lifetime and 20 percent of colorectal cancers are
found after the disease has spread to distant organs." said Amy Kelly,
director and co-founder of the Colon Cancer Alliance. "That means that
a person in the U.S. is diagnosed with colorectal cancer every four
minutes, heightening the need for new therapeutic options such as
Marketing applications were simultaneously submitted to the
European Medicines Agency (EMEA) in April 2006 and Health Canada,
Australia and Switzerland in May 2006. Vectibix is being evaluated in
ongoing clinical trials as both a monotherapy and in combination with
other agents for the treatment of various types of cancer. For more
information please visit www.amgentrials.com.
Important Product Safety Information
As described below, the Vectibix Prescribing Information includes
warning language as part of evolving FDA labeling for the anti-EGFr
Dermatologic toxicities, related to Vectibix blockade of EGF
binding and subsequent inhibition of EGF receptor-mediated signaling
pathways, included but were not limited to dermatitis acneiform,
pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and
skin fissures. Dermatologic toxicities were reported in 89 percent of
patients treated with Vectibix and were severe in 12 percent of
patients. Severe dermatologic toxicities were complicated by
infection, including sepsis, septic death, and abscesses requiring
incisions and drainage. Vectibix may need to be withheld or
discontinued for severe dermatologic toxicities.
Severe infusion reactions occurred with Vectibix in approximately
1 percent of patients. Severe infusion reactions were identified as
anaphylactic reactions, bronchospasm, fever, chills, and hypotension.
Although fatal infusion reactions have not been reported with
Vectibix, they have occurred with other monoclonal antibody products.
Severe infusion reactions require stopping the infusion and possibly
permanently discontinuing Vectibix, depending on the severity and/or
persistence of the reaction.
Other important safety information includes:
The most common adverse reactions to Vectibix were generally mild
to moderate and included skin rash with variable presentations,
paronychia, fatigue, abdominal pain, nausea and diarrhea.
Hypomagnesemia occurred 6 weeks or longer after the initiation of
Vectibix. In some patients, hypomagnesemia was associated with
Amgen(TM) Oncology Assistance
Amgen has expanded its patient assistance programs into a
comprehensive, multifaceted program with a single gateway - Amgen(TM)
Oncology Assistance. Through this program, patients who are uninsured,
underinsured, or unable to afford their insurance co-payments can
receive financial support for Amgen's cancer medicines, including
Vectibix. The Amgen Oncology Assistance program will be available for
U.S. cancer patients and will launch in October. For more information,
please visit www.amgen.com.
About Colorectal Cancer
Colorectal cancer is the third most common cancer diagnosed in men
and in women in the United States. The American Cancer Society
estimated that about 146,940 new cases of colon cancer and 41,930 new
cases of rectal cancer will be diagnosed in 2006. Colorectal cancer is
the second leading cause of cancer death among men and women in the
United States and Canada (after lung cancer). It has been estimated
that 56,370 people will die from colorectal cancer in 2006. That means
that one person in the United States dies of colorectal cancer every
Although EGF receptors normally help regulate the growth of many
different cells in the body, these receptors also can stimulate cancer
cells to grow. In fact, some cancer cells actually require signals
mediated by EGF receptors for their survival. Residing on the surfaces
of these tumor cells, EGF receptors are activated when naturally
occurring proteins in the body, such as epidermal growth factor (EGF)
or transforming growth factor alpha (TGF-alpha), bind to them. This
binding changes the shape of the EGF receptors, which, in turn,
triggers internal cellular signals that stimulate tumor cell growth.
Vectibix binds to EGF receptors, preventing the natural ligands such
as EGF and TGF-alpha from binding to the receptors and interfering
with the signals that might otherwise stimulate growth and survival of
the cancer cell.
Amgen discovers, develops and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the
first companies to realize the new science's promise by bringing safe
and effective medicines from lab, to manufacturing plant, to patient.
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With a broad and deep pipeline of potential new medicines, Amgen
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people's lives. To learn more about our pioneering science and our
vital medicines, visit www.amgen.com.
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Christine Regan, 805-447-5476 (media)
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Arvind Sood, 805-447-1060 (investors)