-The FDA Has Granted Marketing Authority for Mozobil with Granulocyte-Colony Stimulating Factor in Patients with Multiple Myeloma and Non-Hodgkin's Lymphoma-
Many patients scheduled for stem cell transplants could benefit from the FDA approval of Mozobil™ (plerixa for injection). Mozobil releases biological bonds that hold stem cells to the bone marrow so they travel into the blood stream where they are available for harvest. The regimen was approved for patients with multiple myeloma and non-Hodgkin's lymphoma (NHL) in preparation for autologous stem cell transplantation, a standard of care for patients meeting certain medical conditions.
"We believe Mozobil can help patients who are candidates for transplant by increasing the number of stem cells available to be harvested, and shortening the amount of time required for that harvest to take place, "said Susie Novis, President of the IMF. "We applaud new developments such as this with the potential to ease the burden on patients, and reduce the resources required for their care."
According to the Genzyme Corporation that makes Mozobil, studies have shown that the median time required to collect the target number of stem cells was just one day for patients given Mozobil, while patients on placebo required a median number of four days for the required number of cells to be collected. The target number of stem cells required for harvest is at least 6 million cells per kg of body weight.
Stem cell transplantation is an option for many myeloma patients upon completion of frontline therapy. Eligibility for autologous stem cell transplantation is based on factors including patient age and general health, type of myeloma, stage of myeloma, disease aggressiveness and responsiveness to treatment.
Mozobil is now approved for use in the United States in combination with granulocyte-colony stimulating factor (G-CSF). Approval is pending in Europe, Australia, and Brazil with additional applications planned.