OBJECTIVES: Cancer is amongst the leading causes of death globally and was responsible for a total of 8.2 million deaths worldwide in 2012. The aim of this study was to investigate the similarities and differences between the approval of new molecular entities and biologics for the treatment of cancers in Japan and the USA. METHODS: Drugs approved from 2004 to 2013 were identified through publically available reports on the USA Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) websites. Relevant drugs were defined as related to the treatment of neoplasms, according to the World Health Organisation International Classification of Diseases Version 2010. RESULTS: The FDA approved a total of 55 cancer drugs between 2004 and 2013 compared to 45 by the PMDA, of which 24 drugs were approved by both organisations. Although less than half of currently FDA-approved cancer drugs are approved by the PMDA, 87.5% of drugs approved by the FDA between 2004 and 2007 have subsequently been approved by the PMDA with an average delay of 2.95 years. Of the total number of drugs for all indications, 21% of FDA-approved drugs and 16% of PMDA-approved drugs were indicated for oncology. Although the proportion of drugs focused on breast cancer, lymphoma and bone marrow disorders were similar between the two organisations; the FDA had a higher proportion of drugs indicated for leukemias and prostate cancer, whilst the PMDA had a larger focus on colorectal cancer drugs.  CONCLUSIONS: From the analysis presented here, there are clear differences between cancer drug approval in Japan and the USA with regards to time-to-approval of new drugs, as well as the specific treatment areas for which new drugs have been submitted.