Genzyme has received approval from the European Commission for the marketing authorization of Mozobil (plerixafor injection). It is likely to provide a new option for patients with blood cancers lymphoma and multiple myeloma, who require an autologous stem cell transplant.
Mozobil, in combination with granulocyte-colony stimulating factor (G-CSF), is designed to release hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected. This makes it more likely for patients with certain types of cancers to proceed to autologous transplant.
Genzyme has filed applications for the approval of Mozobil in Argentina, Australia, Brazil, Israel, and Singapore, and additional applications are planned globally.
The company expects that with further clinical development, Mozobil will be used in the majority of these procedures. Peak sales of the product in the transplant setting are projected to reach $400m annually.
Paula Soteropoulos, vice president and general manager of Genzyme, said: “There is strong interest among European physicians for Mozobil. With today’s approval, we will move quickly to make this important product broadly available to the transplant community.”