OBJECTIVES:  To investigate regulatory submission strategies employed by manufacturers of anticancer therapies in the US and EU, we sought to identify any discrepancies between the regulatory dossiers submitted to the FDA and EMA for the period of 2012–2016. METHODS:  A review of all relevant FDA-approved oncology products granted marketing approval between 01/01/2012 and 07/15/2016 was conducted, followed by a cross-check to identify any associated CHMP opinions. In order to capture all potential submission delays across post-2012 FDA and EMA new drug applications, data for supplemental NDAs or BLAs submitted during the same period were also collected and cross-checked against the EMA database. Any FDA/EMA application pair associated with a submission delay of 6 or more months was selected for deep-dive assessment. FDA Summary Review, EPARs, and CHMP opinion summaries were consulted to extract data on sponsor application evidence packages and submission timelines. All data were then cross-examined to identify any variations between corresponding applications across the two regulatory agencies. RESULTS:   Of unique NDA and BLA approvals granted by the FDA for the period in question, 41 corresponding conditional or positive CHMP recommendations were identified. 32 additional submissions to the EMA were identified as being associated with FDA approvals for follow-on indications. Three new drug and six follow-on indication FDA/EMA pairs were associated with submission delays of greater than 6 months. Of these nine cases, five were found to have substantial differences in the evidence packages submitted to the respective agencies CONCLUSIONS:  The majority of regulatory submissions for anticancer indications were found to be submitted within similar time frames to both the FDA and EMA. However, the identification of multiple instances of more comprehensive data package submissions to the EMA may allude to potential regulatory strategies utilized by manufacturers to obtain optimal product positioning at launch.