Growth factor allogeneic PBSC mobilization indication requires separate data from autologous setting.

Executive Summary

GROWTH FACTOR ALLOGENEIC PBSC MOBILIZATION INDICATION REQUIRES SEPARATE DATA and should not be extrapolated from data on use of hematopoietic growth factors in peripheral blood stem cell mobilization for autologous transplantion, FDA's Biological Response Modifiers Advisory Committee agreed Nov. 13. Although allogeneic PBSC transplants are performed in many fewer patients than autologous transplants, the committee concurred with FDA Division of Clinical Trial Design & Analysis Director Karen Weiss that "in terms of the labeling, I think that autologous and allogeneic stem cells are different and data should be generated from each of the settings."