Although LeukoSite Inc.'s planned BLA for its Campath-1H anti-CD52 humanized monoclonal antibody relies on open-label Phase II data, the company believes that the data will meet the FDA's requirements and support initial approval of the antibody.

The trial, which was sponsored by the Campath joint venture between LKST (Cambridge, Mass.) and Ilex Oncology Inc. (ILXO, San Antonio, Texas), examined 92 chronic lymphocytic leukemia (CLL) patients who were refractory to fludarabine, the standard treatment for patients who