The FDA has approved a supplemental biologics license application (sBLA) for alemtuzumab (Campath, Genzyme/ Bayer HealthCare) and has granted reg ular approval for single-agent therapy for use in B-cell chronic lymphocytic leukemia. This agent was initially approved in 2001 under accelerated regulations.
Patients receiving alemtuzumab experienced higher overall and statistically significant complete response rates com pared with patients receiving chlorambucil drags.
A boxed warning includes information on cytopenias, infusion reactions, and infections.
(Source: Genzyme/Bayer, September 20, 2007.)