It takes long time and huge cost to develop new drugs. However, average successrate from first-in human to registration in all therapeutic areas is approximately 11%. Notably,success rate in oncology area is 5% or less. Development of new drugs carries out under generalconsideration for clinical trials(ICH E8)and therapeutic guidelines. The treatment landscape ofoncology is rapidly changing. Antineoplastic drugs have been developed from non-specificcytotoxic drugs to specific molecular targeted agents sometimes with companion diagnostics. Theantineoplastic drug should be developed in each type of cancer and this article shows how to developantineoplastic drugs and current treatment landscape in lung cancer, colorectal cancer, and breastcancer as representative cancer types. In addition, development of immunotherapy is emerging inmalignant melanoma and probably beyond this indication.Recently, Ipilimumab (an antibody against cytotoxic T-lymphocyte-associated antigen 4［CTLA-4］) and Vemurafenib (BRAF kinase inhibitor) were approved by US Food and DrugAdministration(FDA). New treatment of immunotherapies incorporates in this article, including theanti-PD-1 antibody which can inhibit newly identified immune check point.
