Bayer: FDA Approves Expanded Labeling for Campath to Include First-line Treatment for Leading Form of Adult Leukemia

Study data demonstrated improved progression-free survival with Campath

24-Sep-2007

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Bayer Schering Pharma AG and Genzyme Corp. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Campath® (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath was initially approved in 2001 under accelerated approval regulations for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The FDA has determined that the study results submitted in the sBLA fulfill the post-marketing commitment to verify clinical benefit. A label expansion to include first-line treatment is under consideration in Europe.

https://www.bionity.com/en/news/69985/bayer-fda-approves-expanded-labeling-for-campath-to-include-first-line-treatment-for-leading-form-of-adult-leukemia.html