FDA approves Genzyme's Mozobil for use in combination with G-CSF for treating patients with NHL and MM blood cancers.Genzyme Corporation, Cambridge, MA, announced the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted marketing approval for Mozobil (plerixafor injection), a drug intended to be used in combination with granulocyte-colony stimulating factor (G-CSF G-CSF granulocyte colony-stimulating factor. G-CSF granulocyte-colony stimulating factor. G-CSF Granulocyte colony-stimulating factor Molecular therapeutics A biological response modifier, the recombinant DNA form of ) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation Autologous transplantation A procedure wherein the person donates blood or tissue to themselves. Mentioned in: Vitiligo in patients with non-Hodgkin's lymphoma non-Hodg·kin's lymphoma n. Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells. Non-Hodgkin's lymphoma (NHL NHL Non-Hodgkin's lymphoma, see there ) and multiple myeloma (MM). The product has also received orphan drug designation. Mozobil is designed to mobilize hematopoietic stem cells from stem cells from the bone marrow into the bloodstream where they can be collected, making it more likely for patients with certain types of cancer to proceed to transplant. The company says 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. In two randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trials - one in patients with NHL, the other in patients with MM - Mozobil combined with G-CSF increased the number of stem cells available for collection and transplantation compared with G-CSF alone. Genzyme says that in addition to its expected benefits for patients, Mozobil may offer economic benefits for transplant centers. The company says the product has the potential to decrease the number of apheresis apheresis (əfĕr`əsĭs), or hemapheresis (hē'məfĕr`əsĭs), any procedure in which blood is drawn from a donor or patient and a component (platelets, plasma, or white blood days and provide transplant centers with predictable and efficient use of the apheresis center. Mozobil may also reduce the number of patients who require a second mobilization procedure due to a failure to mobilize sufficient numbers of cells with current therapy of G-CSF alone. The company says it will commercialize Mozobil in the US through a blood and marrow transplant sales force that are part of its Transplant and Oncology business unit. Genzyme has submitted an application in Europe for approval of Mozobil and expects approval in the second half of this year. The company has also filed applications in Australia and Brazil and additional global applications in up to 60 countries is planned. Approximately 55,000 hematopoietic stem cell transplants are performed each year globally for MM, Hodgkin's and non-Hodgkin's lymphoma. Contact: Web site: www.genzyme.com |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion