Oncology drug approval variations between regulatory agencies contribute to disparate patient access to therapies. This study compared cancer drug approval timelines for Health Canada (HC), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The HC Drug Product Database, Drugs@FDA and European Public Assessment Reports were reviewed to identify submission/approval dates and priority review status for antineoplastic agents approved from 2003-2017. Paired t-tests and one-way repeated-measures ANOVA were used for statistical analysis.
77 drugs were analyzed (HC data was available for 67 drugs, EMA data available for 73 and FDA data available for 77). More drugs were approved by each agency between 2014-2016 than between 2004-2006 (HC 20 vs. 12, FDA 26 vs. 12, EMA 25 vs. 11). Mean FDA time-to-approval was faster than HC or EMA (p < 0.0001, Table). 81.8% of FDA, 37.3% of HC and 27.4% of EMA applications were granted priority review. In all three jurisdictions, drugs granted priority review received approval faster than those undergoing standard review. Application submission timing was similar between FDA and EMA (p = 0.32), but HC submissions were delayed compared to both FDA (mean 287 days, p < 0.0001) and EMA (mean 207 days, p < 0.0001). Final HC drug approval occurred a mean of 467 days after FDA approval (p < 0.0001), and 185 days after EMA approval (p < 0.0001). EMA approval occurred a mean of 273 days after FDA approval (p < 0.0001).Table: 1561PD
Time-to-approval (in days) for oncologic drugs between 2003-2017 for HC, EMA and FDA
|HC (n = 67)||367||346||205 - 893||p < 0.0001 (vs FDA) p = 0.007 (vs EMA)|
|Priority (n = 25)||282||241||205 - 655||p = 0.0001|
|Non-Priority (n = 42)||419||353||208 - 893|
|EMA (n = 73)||423||423||242 - 713||p < 0.0001 (vs FDA)|
|Priority (n = 20)||358||334||242 - 534||p = 0.0005|
|Non-Priority (n = 53)||448||440||289 - 713|
|FDA (n = 77)||209||183||46 - 458||-|
|Priority (n = 63)||183||181||46 - 336||p < 0.0001|
|Non-Priority (n = 14)||329||302||277 - 458|
Significant differences exist between regulatory approval timelines in Canada, the United States and Europe. International collaboration can help to identify and share drug approval best practices, including selection of drugs warranting priority review.
Clinical trial identification
Legal entity responsible for the study
Department of Oncology, Cumming School of Medicine, University of Calgary.
Has not received any funding.
S. Verma: Advisory board: Amgen, AstraZeneca, Eli Lilly, Pfizer, Novartis, Roche, Daiichi, Samsung, Seattle Genetics. All other authors have declared no conflicts of interest.