ROCKVILLE, MarylandFDA has approved expanded labeling for single-agent Campath (alemtuzumab) as a first-line treatment of B-cell chronic lymphocytic leukemia. Campath is the first monoclonal antibody to be approved for first-line use in B-CLL.
In a phase III study, Campath reduced the risk of disease progression or death by 42%, compared with chlorambucil (P = .0001). In addition to meeting its primary endpoint of progression-free survival, Campath patients also had significantly higher overall and complete response rates, compared with chlorambucil. The drug's safety profile was manageable.
The study data were included in the supplemental biologics license application submitted by Genzyme Corp. and Bayer HealthCare Pharmaceuticals Inc in seeking the new first-line treatment indication. Previously, the agent had received accelerated approval as first-line therapy, and the study results fulfill the company's postmarketing commitment to verify clinical benefit.
"Campath is clearly an important single agent for the first-line treatment of CLL," said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, UK, and the lead investigator of the study, which was presented at the 2006 American Society of Hematology annual meeting.
Campath was approved initially in 2001 as a treatment for B-CLL patients who had been previously treated with alkylating agents and who had failed treatment with fludarabine.