European Commission Approves Genzyme’s Mozobil

Product Provides Significant New Option for Certain Cancer Patients Requiring a Stem Cell Transplant

06-Aug-2009 - USA

Genzyme Corporation announced that the European Commission has granted marketing authorization for Mozobil® (plerixafor injection), providing a significant new option for patients with the blood cancers lymphoma and multiple myeloma who require an autologous stem cell transplant.

“Mozobil has the potential to transform the field of stem cell transplantation,” said Mohamad Mohty, MD, PhD, Professor of Hematology and head of the Stem Cell Transplant Program at the University Hospital in Nantes, France. “This new treatment will allow more patients with yet incurable malignancies to confidently move on to a potentially life-saving autologous stem cell transplant.”

In Europe, Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilization of stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilize poorly. This indication allows physicians to use Mozobil in the broad group of patients who are at risk of poor mobilization, as well as those who have previously failed conventional treatment. The product has been granted orphan drug status in the European Union and United States.

Mozobil, in combination with G-CSF, is designed to release hematopoietic stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with certain types of cancers to proceed to autologous transplant. Currently, before a transplant can take place, patients may receive a prescribed dose of chemotherapy and/or other drugs called growth factors to help mobilize their hematopoietic stem cells into the bloodstream. Once the cells are released into the bloodstream, they are collected in preparation for a transplant.

In order for the transplant to take place, a minimum number of approximately two million stem cells per kilogram of body weight must be collected, and physicians may seek two-and-a-half times more stem cells than the minimum transplantable number to allow for better outcomes. For many patients, the stem cell collection process can take three or four hours over multiple days to complete. Even then, some patients are not able to mobilize enough cells, and a transplant is not possible.

Mozobil was evaluated in two randomized, double-blind, placebo controlled, phase 3 studies in patients with non-Hodgkin’s lymphoma and multiple myeloma. Patients were given Mozobil plus G-CSF or placebo plus G-CSF. The studies found that Mozobil in combination with G-CSF increased the number of patients achieving both the minimum and target stem cell levels in fewer apheresis sessions; allowed more patients to proceed to transplant; and increased the predictability of apheresis stem cell yield and timing.

https://www.bionity.com/en/news/104392/european-commission-approves-genzymes-mozobil.html