Therapeutic monoclonal antibodies: trends in development and approval in the US.

Monoclonal antibodies have significant potential as therapeutic agents because of their ability to bind to specific antigens. To determine trends in the clinical development and approval processes for therapeutic mAbs, data on 199 mAbs that entered clinical study from 1980 to 2001 were collected and analyzed. Of the 199 mAbs, 75 are in clinical development, two are undergoing Food and Drug Administration (FDA) review, and 11 are FDA approved. Approval success rates for murine, chimeric and humanized mAbs, and clinical and approval phase lengths for mAbs, are presented. In addition, mAbs that are either in phase III, FDA-review, or are FDA approved for antineoplastic or immunological indications are described.