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Genzyme nabs FDA approval for stem cell mobilizing agent

Genzyme nabs FDA approval for stem cell mobilizing agent

Genzyme has won a nod from the FDA to market Mozobil (plerixafor) in the U.S. The drug is intended to be used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma. The product has also been granted orphan drug designation by the FDA.

Mozobil, a small-molecule CXCR4 chemokine receptor antagonist, is designed to mobilize hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for eligible patients to proceed to transplant.

In studies, 59% of NHL patients who received Mozobil and G-CSF collected the target number of at least five million stems cells/kg of body weight in four or fewer apheresis sessions, compared with 20% for placebo. The median number of days to reach the target cell count was three Mozobil and not evaluable in the placebo group.

Seventy-two percent of patients with multiple myeloma who received Mozobil and G-CSF collected the target number of at least six million stem cells/kg of body weight in two or fewer apheresis sessions, compared with 34% of placebo patients. The median number of days to reach the target cell count was one day for the Mozobil group.

 
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