"Targeted Therapy with Monoclonal Antibodies: The New Generation of Pharmaceuticals"

The last decade has witnessed a revolution in pharmaceutical sciences and commercial products with the introduction and intensification of biological products. Foremost has been the development and commercialization of antibodies, particularly for the therapy of cancer, with 8 such products already approved in the USA and hundreds of product candidates in various stages of clinical development. Although monoclonal antibodies have been pursued as new commercial candidates for about 30 years, advances in antibody engineering were required to de-immunize them for repeated human use, and when used as targeting agents, various constructs with isotopes, drug, and toxins have been developed and commercialized. As new targets become identified, the diverse antibody products are gaining in attention as prospective new therapeutics even beyond cancer, such as in the therapy of autoimmune, infectious, and neurodegenerative diseases. Not only are new antibody constructs of multifunctional nature being developed for enhanced potency, but new delivery systems involving methods of separating the targeting moiety from the effector molecules (radionuclided, drugs, toxins, cytokines), such as in so-called pretargeting methods, are under development. These advances have resulted in the concept of targeted disease therapy, attended by a better safety profile for this new class of pharmaceuticals, and are being used increasingly in combination with conventional cytotoxic drugs approved for the therapy of cancer and immune diseases. These disease-targeting antibodies, however, should soon decrease the dependence on traditional cytotoxic drugs by targeting such agents more selectively as immunoconjugates, especially with pretargeting technologies.