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Genzyme Corporation announced today that it has submitted marketing applications in both the United States and the European Union for Mozobil (plerixafor), a product candidate intended to enhance mobilisation of haematopoietic stem cells for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma.
The company has requested priority review of its US application and, if granted, Mozobil could be approved by the end of this year. European approval is expected in 2009. Additional global applications in up to 60 countries are expected to follow.
Mozobil is designed to mobilise stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for a patient with certain types of cancers to receive a successful transplant.
Specifically, patients with non-Hodgkin’s and Hodgkin’s lymphomas and multiple myeloma often receive high-dose chemotherapy, a process that destroys bone marrow. A stem cell transplant is required to replenish blood-forming bone marrow cells destroyed by high-dose chemotherapy. Stem cells differentiate into the mature red blood cells, white blood cells, and platelets that a healthy person needs.
“There is a lot of excitement among treating physicians about Mozobil,†said Mark Goldberg MD, senior vice president of clinical research at Genzyme.
“The product has great potential to meet an important, unmet medical need and has numerous potential benefits for patients.â€
