FDA Expands Neulasta Label

THOUSAND OAKS, California, September 15, 2005 - Amgen (Nasdaq: AMGN), the world’s largest biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved an update to the Neulasta (pegfilgrastim) prescribing information to include data from a landmark Phase 3 study demonstrating the white blood cell booster helps protect patients with most types of cancer undergoing moderately myelosuppressive chemotherapy from infection, as manifested by febrile neutropenia (low white blood cell count with fever), one of the most serious side effects of chemotherapy.

Previously, first and subsequent cycle administration of Neulasta to stimulate production of infection-fighting white blood cells was indicated for patients receiving myelosuppressive chemotherapy associated with a more than 30 to 40 percent risk of febrile neutropenia. Administration of Neulasta beginning in the first cycle of chemotherapy is now approved for patients receiving myelosuppressive chemotherapy associated with at least a 17 percent risk of febrile neutropenia. Myelosuppressive chemotherapy is toxic to the bone marrow where white blood cells, red blood cells and platelets are produced.

"The Phase 3 study demonstrated that administering Neulasta beginning in the first chemotherapy cycle reduced the incidence of febrile neutropenia by 94 percent," said Willard Dere, M.D., chief medical officer and senior vice president of Global Development at Amgen. "With this approval and Neulasta’s once-per-cycle dosing, physicians can help protect appropriate patients proactively before their white blood cell counts become dangerously low."

The expanded label was based on a randomized, placebo-controlled study of 928 metastatic or non-metastatic breast cancer patients that was published in the Journal of Clinical Oncology earlier this year. First and subsequent-cycle administration of Neulasta resulted in a 94 percent reduction in the incidence of febrile neutropenia (1 percent versus 17 percent with placebo), a 93 percent reduction in the incidence of hospitalization (1 percent versus 14 percent with placebo) and an 80 percent reduction in the incidence of intravenous anti-infective use (2 percent versus 10 percent with placebo), compared to placebo, in patients receiving moderately myelosuppressive chemotherapy.

"Approximately two-thirds of neutropenic complications happen in the first cycle of chemotherapy," said study lead investigator Charles Vogel, M.D., Cancer Research Network, Plantation, Fla. "This study demonstrates that administering Neulasta beginning in the first cycle of chemotherapy reduces the chance of patients developing an infection."

About Neutropenia

Neutropenia is an abnormally low level of neutrophils, important infection-fighting white blood cells, in the blood stream. Neutropenia can put some patients at risk for severe infections and interruptions in cancer treatment. In fact, complications associated with a low white blood cell count are a common cause of dose reductions or delays in chemotherapy.

Febrile (or feverish) neutropenia is the most common presentation of infection in patients receiving chemotherapy. Infection in this setting can be serious and even life threatening because chemotherapy can compromise the patient’s ability to fight infection.

Although white blood cell boosters have been available for more than a decade, only 17 percent of patients receiving myelosuppressive chemotherapy currently receive proactive first-cycle protection from neutropenic complications, which include infection, hospitalization and anti-infective use. Approximately half of the 1.3 million patients receiving chemotherapy are at risk for developing neutropenia.

About Neulasta

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 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 active or placebo controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain. While not reported in patients receiving Neulasta, rare events of adult respiratory distress syndrome have been reported in patients receiving the parent compound, Filgrastim.

Source: Amgen

Posted: September 2005


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