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Clinical development time is shorter for new anticancer drugs approved via accelerated approval in the US or via conditional approval in the EU by Ebru Demirci; Grace Omes‐Smit; Alex Zwiers is a Medicine article available to read on EtoBox.

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## Abstract The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization: (i) drug development (fast track designation (FTD), breakthrough therapy designation (BTD), regenerative medicine advanced therapy designation in the United States, and priority medicines scheme in the European Union), (ii) review of marketing authorization application (priority review in the United States and accelerated assessment in the European Union), (iii) approval of drug (accelerated approval in the United States and conditional approval in the European Union). Typical clinical development time of 76 new anticancer drugs, for which the EMA gave a positive opinion between January 2010 and December 2019, was 6.7 years: 5.8 years for small molecules and 7.7 years for biotechnology‐derived products. Drugs following only BTD (5.6 years) typically had a shorter clinical development time than drugs following only FTD (6.4 years) or both FTD and BTD (6.4 years), compared to drugs not following any expedited regulatory approval program a

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Author

Ebru Demirci; Grace Omes‐Smit; Alex Zwiers

Publisher

Wiley

Published

2023

Language

EN

Field

Medicine (Health Sciences)