Important Safety Information on Campath

The following letter has been endorsed by EMEA for distribution to healthcare professionals in Europe regarding preliminary safety information from CALGB10101. Bayer HealthCare and Genzyme would like to provide the following introductory remarks to this letter. The use of alemtuzumab as consolidation therapy following induction regimens, some of which are also investigational in chronic lymphocytic leukaemia (CLL), is an area of active study. One study exploring the use of alemtuzumab for consolidation is CALGB10101, which was designed and is being conducted by the Cancer and Leukemia Group B (CALGB), a US-based cooperative group. This ongoing study investigates the administration of induction chemotherapy with fludarabine + rituximab (FR) followed by alemtuzumab for remission consolidation in previously untreated symptomatic CLL patients. The preliminary safety information from this study was reported in an abstract that was presented at the 2007 meeting of the American Society of Hematology (ASH) and that described six infection related deaths out of 51 patients who had received FR induction followed by alemtuzumab. The safety information from the CALGB10101 trial is specific to that trial. Outside of the CALGB10101 trial, the published literature, as of January 2008, has reported on 227 patients who received alemtuzumab consolidation after initial induction therapy. In these 227 patients, four drug-related deaths were reported (two infectious, one due to autoimmune hemolytic anemia and one due to cachexia). Many factors may contribute to the risk of infections in CLL patients, such as the specific induction regimen, the dose or schedule of the agents used, as well as the interval between induction and consolidation. The products used in CALGB10101 all have known immunosuppressive properties, and the relative contribution of each drug to the safety outcomes in this study is not clear based on the available data. Investigators participating in oncology trials of alemtuzumab were previously informed of this safety information on November 8, 2007. Further, in response to a request from CHMP, a letter was issued in the EU in February 2008 regarding the safety information on CALGB10101. In response to a request by Health Canada, Bayer HealthCare and Genzyme issued a Health Professional Communication (HPC) in Canada in November 2008. The HPC issued in Canada was based on the same safety information as was described in the Dear Healthcare Professional Letter issued in the EU. As of November 2008, no new significant safety information has been received by Genzyme or Bayer HealthCare regarding CALGB10101. Bayer HealthCare and Genzyme do not plan to issue additional communications in other countries as the use of alemtuzumab as consolidation therapy following induction regimens is unapproved and under active clinical investigation. Genzyme and Bayer HealthCare remain committed to the safe and appropriate development of alemtuzumab in the treatment of CLL, including its potential utility in consolidation. Genzyme and Bayer HealthCare do not recommend the use of alemtuzumab as consolidation therapy following induction regimens outside of a clinical trial.

Please download the official letter endorsed by EMEA for further information.