REGULATORY CONSIDERATIONS FOR PRECLINICAL DEVELOPMENT OF ANTICANCER DRUGS

The entry of new anticancer treatments into phase I clinical trials is ordinarily based on relatively modest preclinical data. This report d efines the battery of preclinical tests important for assessing safety under an Investigational New Drug application (IND) and outlines a ba sis for extrapolating starting doses of investigational anticancer dru gs in phase I clinical trials from animal toxicity studies. Types of p reclinical studies for the support of marketing of a new anticancer dr ug are also discussed. This report addresses differences and similarit ies in the preclinical development of cytotoxic drugs (including photo sensitizers and targeted delivery products), drugs used chronically (c hemopreventive drugs, hormonal drugs, immunomodulators), and drugs int ended to enhance the efficacy (MDR-reversing agents and radiation/chem otherapy sensitizers) or diminish the toxicity of currently used antic ancer therapies. Factors to consider in the design of preclinical stud ies of combination therapies, alternative therapies, and adjuvant ther apies in the treatment of cancer, and to support changes in clinical f ormulations or route of administration, are also discussed.