THOUSAND OAKS, CA and LUCERNE, SWITZERLAND — June 4, 2002 —
Amgen, the world’s largest biotechnology company, today announced that the European Committee on Proprietary Medicinal Products (CPMP) has recommended approval of pegfilgrastim (Neulasta/Neupopeg) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
The CPMP’s recommendation will be forwarded to the European Commission for its approval of the marketing authorization. Neutropenia is a serious and frequent side effect of chemotherapy treatment.
In addition to killing cancer cells, chemotherapy also kills normal cells, including those that protect against infection. This often results in neutropenia, a severe drop in the numbers of a type of white blood cell called neutrophils, which play a vital role in defending the body against most types of infection.
With a severe drop in white blood cells, even a seemingly minor infection can become life threatening. Neupogen® /Granulokine® (filgrastim), Amgen’s other white blood cell stimulating product, has been shown to decrease the risk of infection and hospitalization as a result of chemotherapy-induced neutropenia. However, the burden of daily injections (which sometimes continue for as many as 14 consecutive days) has led many healthcare professionals to wait until after a chemotherapy patient has developed a neutropenic infection before administering filgrastim.
Neulasta is a long-acting form of filgrastim which allows for once-per-chemotherapy cycle dosing. In addition to reducing the burden associated with daily injections, simple, once-per-chemotherapy- cycle administration of Neulasta may increase adherence to treatment regimens and eliminate the potential for missed doses of growth factor.
“This once-per-cycle product can have a very positive impact on patients’ quality of life,” said Professor Martine Piccart, of the Institute Jules Bordet, in Belgium, an investigator in the pivotal, fixed dose, pegfilgrastim study conducted in Europe.
Neulasta is a pegylated recombinant protein that stimulates the production of neutrophils that are depleted by cytotoxic chemotherapy.
תגובות רוצה להצטרף לדיון?
יש להתחבר כדי להגיב.
התחבראין תגובות עדיין. היה הראשון להגיב!