New Indication For Immunex' Leukine
Immunex has filed a supplemental New Drug Application in the USA for its Leukine (sargramostim) for use in peripheral blood stem cell mobilization for transplantation. The company claims to be the first to ask for Food and Drug Administration approval of a growth factor for PBSC mobilization.
The new application contains data on 296 cancer patients undergoing the collection of PBSCs using apheresis, with and without Leukine. The study shows that Leukine reduced the number of apheresis procedures needed to collect enough PBSCs for transplantation, while achieving a higher yield of stem cells. Time to engraftment and the number of days in hospital were also decreased in the Leukine-treated group.
The company recently filed for approval of a new liquid intravenous formulation of the drug. It is currently supplied only as a freeze-dried powder for reformulation.
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