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:2021:10.1200/jco.2021.39.15_suppl.1575,
author = {Lythgoe, M and Krell, J and Warner, JL and Desai, A and Khaki, AR},
doi = {10.1200/jco.2021.39.15_suppl.1575},
journal = {Journal of Clinical Oncology},
pages = {1575--1575},
title = {Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals.},
url = {http://dx.doi.org/10.1200/jco.2021.39.15_suppl.1575},
volume = {39},
year = {2021}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background: Novel therapies are transforming cancer care. Regulatory review and approval are essential to deliver safe and efficacious innovations to patients. Studies prior to 2010 describe quicker approval decisions for new oncology drug registrations with the FDA compared to the EMA (median delay 238 days). Both regulatory agencies have subsequently improved procedures to expedite approval times. We compared regulatory market authorisation dates at the FDA and EMA for new oncology therapies from 2010-2020. Methods: New oncology therapeutic approvals between 2010-2020 were identified from the FDA and EMA regulatory databases. We analysed only initial approvals (not supplementary licenses) for active anti-cancer therapies (excluding biosimilars and supportive drugs). The delay in regulatory approval between the FDA and EMA was calculated in calendar days. We further analysed therapies by therapeutic class, evaluating for significant differences. Results: We identified 108 new therapy registrations during the study period. 104 (96.3%) therapies were approved by the FDA and 90 (83.3%) had EMA market authorisation. 4 (3.7%) drugs were not FDA registered, including 3 unsuccessful applications and 1 which sought licensing in a different indication. 18 (16.5%) drugs were not EMA registered, including 9 (8.8%) which did not pursue EMA licensing, 3 (2.9%) withdrawn licensing applications, 3 (2.9%) sought licensing in different tumour group/indication, 1 (0.9%) rejected application and 2 (1.9%) with applications under review at submission date. Of the 86 drugs approved by both agencies, 80 were approved first by the FDA and 6 by the EMA. The median delay in approval between the FDA and EMA was 227 days (IQR:124-354 days). Table shows approvals by therapeutic class. The shortest median time difference for approval was for monoclonal antibodies (171 days) with the longest for kinase inhibitors (281 days). Conclusions: This study shows more new oncology therapies are approved
AU  - Lythgoe,M
AU  - Krell,J
AU  - Warner,JL
AU  - Desai,A
AU  - Khaki,AR
DO  - 10.1200/jco.2021.39.15_suppl.1575
EP  - 1575
PY  - 2021///
SN  - 0732-183X
SP  - 1575
TI  - Time intervals between U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) new cancer therapy approvals.
T2  - Journal of Clinical Oncology
UR  - http://dx.doi.org/10.1200/jco.2021.39.15_suppl.1575
UR  - https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.1575
UR  - http://hdl.handle.net/10044/1/89370
VL  - 39
ER  -
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