1036O_PR - Cross-comparison of cancer drug approvals among international regulatory bodies

Date 28 September 2014
Event ESMO 2014
Session Public health and health economics
Topics Bioethics, Legal, and Economic Issues
Presenter Nardin Samuel
Citation Annals of Oncology (2014) 25 (5): 1-41. 10.1093/annonc/mdu438
Authors N. Samuel1, S. Verma2
  • 1Faculty Of Medicine, MD/PhD Program, University of Toronto, M5S 1A8 - Toronto/CA
  • 2Medical Oncology, Sunnybrook Odette Cancer Center, M4N 3M5 - Toronto/CA




The therapeutic care of cancer patients is significantly impacted by timely access to drugs that improve survival and overall patient outcomes. The key objective of this study was to examine the drug approval process and time to approval (TTA) by three international regulatory bodies–Health Canada, United States Food and Drug Administration (FDA) and European Medicines Agency (EMA).


The publicly available Health Canada Drug Product Database was surveyed for all currently marketed anti-neoplastics approved between January 1, 2005–June 1, 2013. For this set of cancer drugs, data was obtained on submission and approval dates by Health Canada, FDA and EMA and TTAs were calculated from the dates of initial drug submission filing to final approval for marketing.


Using Health Canada as a comparative benchmark, we identified 41 antineoplastic agents that met the study criteria. Overall, the time to approval (TTA) is significantly less for the FDA when compared with the EMA (x¯ = 6.0 months, p < 0.001) and Health Canada (x¯ = 7.6 months, p < 0.001). There was no overall significant difference in TTA between Health Canada and the EMA (x¯ = 3.43 months, p = 0.446). Azactidine (Vidaza®), approved for hematological malignancies, had the greatest delay (66.1 months) between FDA and Health Canada approval. The EMA approved azactidine 10.3 months earlier than Health Canada but 55.8 months following FDA approval. Among all drugs assessed cabazitaxel (Jevtana®), approved for metastatic prostate cancer, was associated with the shortest TTA by the FDA at only 17 days. In Canada and Europe, the TTAs for cabazitaxel were 11.63 months and 11.03 months, respectively. Regarding drug approval timelines, on average, cancer drugs are approved by the FDA 20.6 months earlier than Health Canada. The EMA approves cancer drugs an average of 10.0 months earlier than Health Canada, while the FDA approvals are an average of 24.9 months earlier than the EMA.


This is the first study to systematically compare cancer drug approvals between three major regulatory bodies. We anticipate that the differences in drug approval times can create a dialogue between clinicians and government agencies to understand the current challenges in approval processes and work jointly towards improving them.


All authors have declared no conflicts of interest.