Imperial College London
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DrJonathanKrell

Faculty of Medicine, Department of Surgery & Cancer

Clinical SL in Medical Oncology (Gynaecological Oncology)
 
 
 
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Contact

 

j.krell

 
 
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Location

 

Institute of Reproductive and Developmental BiologyHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Lythgoe:2022:10.1001/jamanetworkopen.2022.16183,
author = {Lythgoe, M and Desai, A and Gyawali, B and Savage, P and Warner, JL and Krell, J and Khaki, AR},
doi = {10.1001/jamanetworkopen.2022.16183},
journal = {Jama Network Open},
title = {Cancer therapy approval timings, review speed and publication of pivotal registration trials in the US and Europe from 2010-2019},
url = {http://dx.doi.org/10.1001/jamanetworkopen.2022.16183},
volume = {5},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Importance: Ensuring patients have access to safe and efficacious medicines in a timely manner is an essential goal for regulatory agencies, which has particular significance in oncology due to the significant unmet need for new therapies. The two largest regulatory agencies, the FDA and 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: A review of 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. Main Outcome Measures: Regulatory approval date, review time, submission of market authorization application, accelerated approval or conditional marketing authorisation 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 (95%) oncology therapies before European authorization and 4 (5%) therapies after. The median delay in market authorization for new oncology therapies in Europe was 241 days compared to the US. The median review time was 200 days and 426 days for the FDA and EMA, respectively. 60 (67%) new licensing applications were submitted to the FDA first, compared to 25 (28%) to the EMA. 35 (39%) oncology therapies were approved by the FDA prior to pivotal study publication, whereas only 8 (9%) by the EMA.Conclusion and Relevance: In this study we demonstrate that new oncology therapies are approved earlier in the US than Europe. The FDA receives licensing applications sooner and has shorter review times. However, mor
AU  - Lythgoe,M
AU  - Desai,A
AU  - Gyawali,B
AU  - Savage,P
AU  - Warner,JL
AU  - Krell,J
AU  - Khaki,AR
DO  - 10.1001/jamanetworkopen.2022.16183
PY  - 2022///
SN  - 2574-3805
TI  - Cancer therapy approval timings, review speed and publication of pivotal registration trials in the US and Europe from 2010-2019
T2  - Jama Network Open
UR  - http://dx.doi.org/10.1001/jamanetworkopen.2022.16183
UR  - http://hdl.handle.net/10044/1/97095
VL  - 5
ER  -
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