Drugs Xagena
Bayer Schering Pharma AG and Genzyme Europe BV have informed Healthcare Professionals
on six infection-related deaths, reported from a trial ( CALGB10101 ) in which previously untreated, symptomatic B-cell chronic lymphocytic leukemia patients were treated with Fludarabine ( Fludara ) and Rituximab ( MabThera, Rituxan ) followed by Alemtuzumab ( MabCampath ) for remission consolidation.
MabCampath is approved for the treatment of patients with B-cell chronic lymphocytic leukaemia ( B-CLL ) for whom Fludarabine combination chemotherapy is not appropriate and should not be used as consolidation therapy following induction with Fludarabine + Rituximab outside of a
clinical trial.
Fludarabine, Rituximab and Alemtuzumab all have known immunosuppressive properties, and it is possible that the fatal infectious complications which occurred in this trial are the result of a prolonged period of immunosuppression resulting from the sequencing of these drugs
without sufficient time for recovery, as well as other factors specific to this trial.
Source: MHRA, 2008
XagenaMedicine_2008
