Filgrastim (r-metHuG-CSF): The First 10 Years

摘要: T HAS BEEN KNOWN for at least three decades that very specific factors control hematopoiesis, acting on early cells in the hematopoietic system to produce mature, functional cells. The isolation, purification, and cloning of these has lead a new class therapeutic agents, including colony-stimulating interleukins. This review is devoted granulocyte factor (G-CSF), specifically Filgrastim (r-metHuG-CSF), bacterially synthesized recombinant protein form GCSF, acts neutrophils, body's major defense against infections. purification molecular were performed between 1984 1986,L-3 clinical development commenced 1986, with approval use cancer patients treated chemotherapy4" obtained United States February 1991. In 5 years since its approval, 1.2 million have been (Amgen [Thousand Oaks, CA], data file). was initially used as an adjunct chemotherapy ameliorating neutropenia, one side effects chemotherapy. Its led reduced infections hospital admissions cancer. Besides chemotherapy-induced approved more than 70 countries treatment myelosuppression after bone marrow transplantation, severe chronic neutropenia (SCN), acute leukemia, aplastic anemia (AA), myelodysplastic syndromes (MDS), mobilization peripheral blood progenitor (PBPCs) transplantation. made possible delivery full-dose high-dose benefited who are immunocompromised. A second rHuG-CSF (lenograstim) received Europe 1993. biologic properties lenograstim similar given Table 1. focuses reviews first 10 postapproval well additional potential applications. PHARMACOLOGY OF FlLGRASTlM pharmacodynamics pharmacokinetics studied rodents',' primates"." then normal volunteers malignant disease. results studies indicated had consistent predictable pharmacologic profile when ad