publication date: Jan. 24, 2014


FDA News

FDA Approves Reagent System for Graft-Versus-Host Disease

FDA approved Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from a matched related donor.

The system removes donor T cells from the graft prior to transplantation by enriching CD34+ blood stem cells, which go on to repopulate the patient’s immune and blood building systems.

Approval was based on data from a phase II, single-arm, multi-center study (BMT CTN 0303) conducted by the Blood and Marrow Transplant Clinical Trials Network.

The trial showed that following intensive myeloablative conditioning, stem cell transplantation from an identical sibling donor processed using the system as the sole means of GVHD prophylaxis lead to a low incidence of chronic GVHD (19 percent at two years after transplantation) without negatively affecting relapse, engraftment, overall survival or disease-free survival.

FDA launched an advisory committee membership nomination portal that allows individuals to submit nominations for membership to any of the agency’s 33 advisory committees.

The portal allows applicants to complete their entire application online. Currently, applications must either be emailed or mailed to the agency.

Nominations for scientific members and consumer and industry representatives may be submitted by professional societies, industry and consumer groups, and other interested persons and organizations.

Potential candidates are asked to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts in order to permit evaluation of possible sources of conflict of interest.

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