CPMP Approves BMT Replacement Approach

The European Union's Committee on Proprietary Medicinal Products has recommended approval of Amgen's Neupogen/Granulokine (filgrastim) for the mobilization of autologous peripheral blood progenitor cells, alone or following myelosuppressive chemotherapy, in order to accelerate hematopoietic recovery by infusion of the cells after myelosuppressive or myeloablative chemotherapy. Filgrastim becomes the first agent to be approved for this indication.

Stem cell infusion with colony stimulating factors has emerged as one of the most promising methods of providing hematological support, and there are hopes that it may supersede bone marrow transplantation for this purpose, for example in cancer patients undergoing chemotherapy.

In trials, stem cell infusion using PBPC's mobilized by filgrastim has been shown to be associated with a reduced risk of severe infection and bleeding, fewer platelet transfusions, less intravenous antibiotic use, fewer days in hospital and lower cost of treatment than traditional bone marrow transplants.