The US 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, Amgen, leading biotechnology company announced here.
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 per cent 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 per cent," Willard Dere, chief medical officer and senior vice president of Global Development at Amgen said adding, "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 per cent versus 17 per cent with placebo), a 93 per cent reduction in the incidence of hospitalization (1 percent versus 14 per cent 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.
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.