Amgen (NASDAQ:AMGN) today announced results from an integrated
analysis showing primary prophylactic use of Neulasta(R)
(pegfilgrastim), a granulocyte colony stimulating factor (G-CSF), with
unique neutrophil-mediated clearance, decreased febrile-neutropenia
(FN) hospitalizations by more than half (4 percent vs. 10 percent)
when compared to current practice neutropenia management and reduced
chemotherapy dose reductions by nearly two-thirds (9 percent vs. 24
percent). The results were presented as an oral presentation at the
14th European Cancer Conference (ECCO) in Barcelona, Spain (Abstract #
2.033).
"Febrile neutropenia, or a low white blood cell count accompanied
by fever, is one of the most serious adverse events related to
myelosuppressive chemotherapy and is still a common cause of
hospitalizations and associated infection-related deaths," said G. Von
Minckwitz, M.D., Ph.D., University of Frankfurt, German Breast Group
GBG Forschungs GmbH, Frankfurt, Germany. "These study findings
emphasize the benefits of primary prophylactic use of Neulasta."
In this integrated analysis of 2,282 breast cancer patients, 9
percent of patients who received primary prophylaxis with Neulasta had
chemotherapy dose reductions compared to 24 percent of patients who
received current practice neutropenia management. Additionally, the
analysis showed that prophylactic use of Neulasta resulted in 4
percent FN hospitalizations versus 10 percent for current practice.
The results presented today expand on the positive outcomes from the
same study first presented at American Society of Clinical Oncology
(ASCO) Breast Symposium in San Francisco earlier this month, which
showed that primary prophylaxis with Neulasta significantly reduced
the incidence of FN compared to current neutropenia management (five
percent vs. 29 percent).
An abnormally low white blood cell count can be serious because
the body's ability to fight off infections becomes impaired, and even
a minor infection can become life-threatening. Importantly,
neutropenia is the major dose-limiting side effect of myelosuppressive
chemotherapy and is the primary reason for chemotherapy dose delays
and reductions. Current European Organization for Research and
Treatment (EORTC), National Comprehensive Cancer Network (NCCN), and
ASCO neutropenia guidelines recommend routine growth factor primary
prophylaxis for patients with an overall FN risk greater than or equal
to 20 percent.
About the Analysis
For this integrated analysis, studies involving breast cancer
chemotherapy regimens with moderate (15-20 percent)/high (greater than
or equal to 20 percent) risk of febrile neutropenia were identified by
literature review. Individual patient data were available from eight
clinical trials and three observational studies (conducted between
1998 and 2005) involving these regimens and primary prophylactic use
of Neulasta (6 mg dose in all cycles) or current practice neutropenia
management (defined as no G-CSF or pegfilgrastim / daily G-CSF in any
cycle). Of the 2,282 patients analyzed, 1,303 received Neulasta as
primary prophylaxis and 979 were treated based on current practice.
About Neulasta
Neulasta is approved to decrease the incidence of infection, as
manifested by febrile neutropenia, in patients with non-myeloid
malignancies receiving myelosuppressive anticancer drugs associated
with a clinically significant incidence of febrile neutropenia.
Similar indications for Neulasta were approved in Europe and Australia
in 2002.
Important Product Safety Information
Splenic rupture (including fatal cases), acute respiratory
distress syndrome, and sickle cell crises have been reported. Allergic
reactions, including anaphylaxis, have also been reported. The
majority of these reactions occurred upon initial exposure. However,
in rare cases, allergic reactions, including anaphylaxis, recurred
within days after discontinuing antiallergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher
incidence in Neulasta-treated patients as compared to placebo-treated
patients (31 percent vs. 26 percent). The most common adverse events
reported in either placebo- or active-controlled trials were
consistent with the underlying cancer diagnosis and its treatment with
chemotherapy, with the exception of bone pain.
Prescribers are recommended to consult regional prescribing
information before prescribing Neulasta, particularly in relation to
side-effects, precautions and contra-indications.
About Amgen
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.
Amgen therapeutics have changed the practice of medicine, helping
millions of people around the world in the fight against cancer,
kidney disease, rheumatoid arthritis and other serious illnesses. With
a deep and broad pipeline of potential new medicines, Amgen remains
committed to advancing science to dramatically improve people's lives.
To learn more about our pioneering science and our vital medicines,
visit www.amgen.com.
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