SCIENTIFIC DISCUSSION This module reflects the initial scientific discussion for the approval of Busilvex. For information on changes after approval please refer to module 8. 1. Introduction

Autologous stem cell transplantation involves the reinfusion of the patient’s own stem cells, previously harvested and cryopreserved in liquid nitrogen, to reconstitute the haematopoietic cell function after the administration of high-dose therapy. The infused stem cells are obtained from the patient’s bone marrow or peripheral blood at a time when the marrow displays minimal or no disease infiltration. Therefore, immunologic transplantation barriers do not exist but, theoretically, the tumour contamination of the graft may increase the relapse rate.