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Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe,
Mark P Lythgoe1, Aakash Desai2, Bishal Gyawali3
1Department of Surgery and Cancer, Imperial College London, London, United Kingdom.
Importance:
Ensuring patients have access to safe and efficacious medicines in a timely manner is an essential goal for regulatory agencies, one which has particular importance in oncology because of the substantial unmet need for new therapies. The 2 largest regulatory agencies, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have pivotal global roles, and their recommendations and approvals are frequently followed by other national regulators.
Objective:
To compare market authorization dates for new oncology therapies approved in the US and Europe over the past decade and to examine and contrast the regulatory activities of the FDA and EMA in the approval of new cancer medicines.
Design, Setting, And Participants:
This cross-sectional study reviewed the FDA and EMA regulatory databases to identify new oncology therapies approved in both the US and Europe from 2010 to 2019, and characterization of the timings of regulatory activities. Statistical analysis was performed from January to April 2022.
Main Outcomes And Measures:
Regulatory approval date, review time, submission of market authorization application, accelerated approval or conditional marketing authorization status and proportion of approvals prior to peer-reviewed publication of pivotal trial results.
Results:
In total, 89 new concomitant oncology therapies were approved in the US and Europe from 2010 to 2019. The FDA approved 85 oncology therapies (95%) before European authorization and 4 therapies (5%) after. The median (IQR) delay in market authorization for new oncology therapies in Europe was 241 (150-370) days compared with the US. The median (IQR) review time was 200 (155-277) days for the FDA and 426 (358-480) days for the EMA. Sixty-four new licensing applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA. Thirty-five oncology therapies (39%) were approved by the FDA prior to pivotal study publication, whereas only 8 (9%) by the EMA.
Conclusion And Relevance:
In this cross-sectional study, new oncology therapies were approved earlier in the US than Europe. The FDA received licensing applications sooner and had shorter review times. However, more therapies were approved prior to licensing study publication, leaving uncertainty for practitioners regarding clinical utility and safety of newly approved therapies.
Insights
The US Food and Drug Administration (FDA) approved new oncology therapies faster than the European Medicines Agency (EMA). However, the FDA approved more treatments before study publication, raising safety and utility questions.
Area of Science:
- Regulatory Science
- Oncology Drug Approval
- Comparative Effectiveness
Background:
- Timely patient access to novel oncology therapies is critical due to significant unmet needs.
- The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are global leaders in drug regulation.
- Their approval decisions influence national regulatory bodies worldwide.
Purpose of the Study:
- To compare market authorization timelines for new oncology drugs in the US and Europe over a decade.
- To analyze and contrast the regulatory processes of the FDA and EMA for cancer medicine approvals.
Main Methods:
- A cross-sectional study of FDA and EMA databases from 2010-2019.
- Identification of new oncology therapies approved in both regions.
- Characterization of regulatory activity timings and approval outcomes.
Main Results:
- 89 new oncology therapies were approved in the US and Europe between 2010-2019.
- The FDA approved 95% of therapies before European authorization, with a median delay of 241 days in Europe.
- FDA review times were shorter (200 days) than EMA's (426 days), with more FDA approvals preceding peer-reviewed publication (39% vs. 9%).
Conclusions:
- New oncology therapies receive market authorization earlier in the US compared to Europe.
- The FDA demonstrates faster application receipt and review times.
- Earlier approvals by the FDA, particularly before publication, may create uncertainty regarding clinical utility and safety for practitioners.
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