Genzyme Corp. and Bayer HealthCare have submitted a sBLA to the FDA to expand the current product label for Campath to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-CLL patients who have been previously treated with an alkylating agent and have failed fludarabine therapy. Genzyme also plans to make a similar filing in Europe to support this label expansion.
The product is marketed outside the U.S. as MabCampath, by Bayer Schering Pharma AG, Germany and in the U.S. by Bayer HealthCare Pharmaceuticals, as Campath. The Phase III study was an international, randomized, controlled trial to satisfy a post-approval commitment to the FDA to show clinical benefit of Campath in B-CLL, and to complete the conversion to regular approval. Genzyme's confirmatory study was completed in accordance with FDA timelines.