Letter from the Editor

The field of monoclonal antibody (mAb) development seems poised to undergo rapid change. The current circumstances recall an extraordinary 10 month period between November 1997 and September 1998 when six mAbs, rituximab, trastuzumab, infliximab, daclizumab, basiliximab, and palivizumab, were approved by the US Food and Drug Administration (FDA). At the time, these therapeutics represented important advances in the treatment of serious or life-threatening diseases including lymphoma, breast cancer, Crohn disease, prevention of kidney transplant rejection, and prevention of respiratory syncytial viral infection. We are in similar circumstances with regard to the numbers, with five mAbs currently undergoing FDA review for anticancer, immunological and antiviral indications, and one under review for treatment of bone disorders. The candidates in review are ofatumumab, tocilizumab, ustekinumab, golimumab, motavizumab and denosumab. Brief reviews of the clinical development of several of these candidates are included in this issue of mAbs.