FDA Grants Priority Review of Panitumumab for Treatment of Patients with Metastatic Colorectal Cancer
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 12, 2006--Amgen
(Nasdaq:AMGN), the world's largest biotechnology company, today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the Biologic License Application (BLA) for panitumumab, an
investigational fully human monoclonal antibody that targets the
epidermal growth factor receptor (EGFr) and has granted Priority
Review. The BLA was submitted for the treatment of metastatic
colorectal cancer patients who have failed prior chemotherapy,
including oxaliplatin and/or irinotecan containing regimens. A
Priority Review designation means that the FDA will target an Agency
action within six months of the application's submission date.
Priority Review status is assigned by the FDA to those
applications the Agency has deemed to have the potential to provide a
significant therapeutic advance for patients. The rolling BLA
submission for panitumumab was initiated in December 2005 and
completed in March 2006. Panitumumab received Fast Track designation
from the FDA in July 2005. In April 2006, marketing applications were
submitted to the European Medicines Agency (EMEA) and Health Canada
and in May 2006 in Australia and Switzerland.
Patients and physicians can access www.amgentrials.com for more
information about ongoing panitumumab clinical trials.
Panitumumab is an investigational fully human monoclonal antibody
that targets the epidermal growth factor receptor (EGFr), a protein
that plays an important role in cancer cell signaling. Panitumumab, an
IgG2 monoclonal antibody, binds with high affinity to the EGFr.
Panitumumab was generated with XenoMouse(R) technology, which creates
a fully human monoclonal antibody that contains no murine (mouse)
protein. The body's immune system can recognize the mouse protein
found in chimeric and humanized antibodies as foreign and may launch
an immune response. The goal of developing fully human monoclonal
antibodies is to offer effective targeted therapies with minimum risk
of immune response against these agents.
Panitumumab is being evaluated in clinical trials as both a
monotherapy and in combination with other agents for the treatment of
various types of cancer, including colorectal, lung and head and neck.
About the Epidermal Growth Factor Receptor (EGFr)
Although EGFr normally helps regulate the growth of many different
cells in the body, EGFr also can stimulate cancer cells to grow. In
fact, many cancer cells actually require signals mediated by EGFr for
their survival. Residing on the surface of these tumor cells, EGFr is
activated when naturally occurring proteins in the body, such as
epidermal growth factor (EGF) or transforming growth factor alpha
(TGF-alpha), bind to it. This binding changes the shape of EGFr,
which, in turn, triggers internal cellular signals that stimulate
tumor cell growth. Panitumumab binds to EGFr, preventing the natural
ligands such as EGF and TGF-alpha from binding to the receptor and
interfering with the signals that would otherwise stimulate growth of
the cancer cell and allow it to survive.
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
estimates that about 106,680 new cases of colon cancer and 41,930 new
cases of rectal cancer will be diagnosed in 2006.
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Trish Hawkins, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.