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Large Community-Based Clinical Trial in Older Cancer Patients Suggests Benefits of Neulasta in First and Subsequent Cycles Of Chemotherapy
ORLANDO, Fla.--(BUSINESS WIRE)--May 15, 2005--Amgen Inc., (NASDAQ:AMGN) the world's largest biotechnology company, today announced that an initial report from a study of 701 older cancer patients with solid tumors demonstrates Neulasta(R) (pegfilgrastim) administered beginning in the first cycle of myelosuppressive chemotherapy resulted in reductions in febrile neutropenia (low white blood cell count with fever) and related complications, compared to those who received Neulasta in later chemotherapy cycles after developing a low white blood cell count. The study results were presented at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). (Abstract #8111)
"Despite the fact that more than 60 percent of cancers are diagnosed in patients 65 years or older, these patients may be under-represented in clinical trials and may also be under-treated, partly due to concern over treatment side effects, such as neutropenia, which may lead to hospitalizations and dose delays or reductions," said Lodovico Balducci, M.D., professor of medicine and oncology, University of South Florida College of Medicine, and division chief of the Senior Adult Oncology Program at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla. "This is the largest, prospective study of older patients demonstrating the feasibility of community-based clinical trials in these patients, as well as the ability of these patients to undergo myelosuppressive chemotherapy."
The study showed a decrease of approximately 60 percent in the incidence of febrile neutropenia across all cycles (4 percent versus 10 percent, respectively), as well as a 50 percent decrease in chemotherapy dose reductions (7 percent versus 14 percent) in patients receiving Neulasta beginning in the first cycle of chemotherapy compared to those who received Neulasta in later cycles. Febrile neutropenia, the primary endpoint of the study, was defined as an absolute neutrophil count (ANC) less than 1 x 10(9)/L and temperature greater than or equal to 38 degrees C. Further, patients receiving Neulasta in the first cycle of chemotherapy experienced almost half the number of neutropenia-related hospitalizations (5 percent versus 9 percent) and a decrease in antibiotic use due to neutropenia compared to those who received Neulasta in later cycles.
The 701 older patients (65 years and older) with lung, breast or ovarian cancer in this study were randomized to receive Neulasta in the first cycle of myelosuppressive chemotherapy (n=349) or Neulasta in second and subsequent chemotherapy cycles at the physician's discretion (n=352).
In this study, serious adverse events were reported less frequently in patients receiving Neulasta in the first and subsequent cycles of chemotherapy than in the group receiving second and subsequent cycle Neulasta. The most frequently reported serious adverse events were febrile neutropenia, neutropenia, pneumonia and dehydration.
Neutropenia is an abnormally low level of neutrophils, an important infection-fighting white blood cell (WBC), in the blood stream. An abnormally low WBC count can be serious because the body's ability to fight off infections becomes impaired, and even a minor case of the flu can become life-threatening. Because of its potential dangers, chemotherapy-induced neutropenia, may cause a patient's chemotherapy to be put on hold or the dose reduced, which can potentially compromise the chemotherapy's effectiveness.
Studies have shown that neutropenia occurs most frequently in the early cycles of chemotherapy, with the majority of febrile (or feverish) neutropenic events occurring in cycles one and two. Approximately half of the 1.3 million patients receiving chemotherapy are at risk for developing neutropenia.
Neulasta was approved by the U.S. Food and Drug Administration (FDA) in 2002 for decreasing 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 the same year.
Rare cases of splenic rupture and sickle cell crises have been reported in postmarketing experience. 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 anti-allergic treatment. In clinical trials, the only serious adverse event not attributed to the underlying disease or chemotherapy was a case of hypoxia. The most common adverse event attributed to Neulasta was bone pain, reported in 26 percent of patients. While not reported in patients receiving Neulasta, rare events of adult respiratory distress syndrome have been reported in patients receiving the parent compound, filgrastim.
Amgen is a global biotechnology company that discovers, develops, manufactures and markets important human therapeutics based on advances in cellular and molecular biology.
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Amgen's Form 10-K for the year ended December 31, 2004, and in Amgen's periodic reports on Form 10-Q and Form 8-K. Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Full prescribing information for Neulasta is available at www.NEULASTA.com or via fax by calling (800) 772-6436. Consumers can call (866) 611-DRUG (3784) for more information.
Kristen Davis, 805-447-4587 (media)
Arvind Sood, 805-447-1060 (investors)
SOURCE: Amgen Inc.