Breaking News, Trials & Filings

Genzyme Files for Expanded Campath Label

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 MabCamp...

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