Abstract
The clinical benefits of an anti-cancer drug need to be demonstrated by clinical studies before they are approved by a regulatory agency. Recent progress in the development of drugs acting on the immune system and in using cancer genomic medicine to target rare molecular subtypes has significantly altered the approach for the clinical development of anti-cancer drugs. Drugs acting on the immune system have different characteristics from those of cytotoxic agents and molecular targeted drugs. For example, the anti-tumor effects of immune checkpoint inhibitors may be delayed, and new adverse events may occur several months after the start of treatment.
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