BARCELONA, Spain--(BUSINESS WIRE)--Sept. 26, 2007--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.
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.
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