CHMP recommends extending the approval of Mozobil in lymphoma or solid malignant tumours

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mozobil (plerixafor), from Genzyme Europe, adding an additional indication for paediatric patients (1 to less than 18 years) in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either: pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or who previously failed to collect sufficient haematopoietic stem cells.