View Full Version : Plerixa Injection Approved in EU to Enhance Mobilisation of Stem Cells for non-Hodgki

08-06-2009, 04:04 PM
Plerixa Injection Approved in EU to Enhance Mobilisation of Stem Cells for non-Hodgkin's lymphoma and multiple myeloma.

NEW YORK -- August 5, 2009 -- The European Commission has approved plerixa for injection (Mozobil) to enhance mobilisation of stem cells in patients with lymphoma or multiple myeloma who require an autologous stem cell transplant, but are at risk of poor mobilisation or have previously failed conventional treatment.

"[Plerixa] has the potential to transform the field of stem cell transplantation," said Mohamad Mohty, MD, Stem Cell Transplant Program at the University Hospital, 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."

Plerixa for injection was evaluated in 2 randomised, double-blind, placebo controlled, phase 3 studies in patients with non-Hodgkin's lymphoma and multiple myeloma.

Patients were given plerixa plus granulocyte-colony stimulating factor (G-CSF) or placebo plus G-CSF.

Results showed that plerixa 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.
Year-long follow-up data also showed that the graft durability rates were comparable in the plerixa plus G-CSF and placebo plus G-CSF trial arms.

SOURCE: Genzyme