The FDA has approved Mozobil (plerixafor, from Genzyme), injection to be used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM).
This approval is based on clinical studies wherein 59% of NHL patients on Mozobil and G-CSF collected the target number of at least 5 million stem cells per kg of body weight in ≤4 apheresis sessions compared to 20% on placebo. Seventy-two percent of MM patients on Mozobil and G-CSF collected the target number of at least 6 million stem cells per kg of body weight in ≤2 apheresis sessions compared to 34% on placebo. The median number of days to reach to reach target cell count was 1 day for the MM Mozobil group as compared to 4 days for the placebo group. Additionally, updated 12-month follow-up findings showed that graft durability rates for patients in the Mozobil plus G-CSF and placebo plus G-CSF arms were comparable..
Mozobil is expected to be available by early first quarter of 2009.
For more information call (877) 4MOZOBIL or visit www.mozobil.com.