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@article{2251415,
author = {Karres, Dominik and Lesa, Giovanni and Ligas, Franca and Benchetrit, Sylvie and Galluzzo, Sara and Karen, Van Malderen and Štěrba, Jaroslav and Maaike, van Dartel and Renard, Marleen and Sisovsky, Peter and Wang, Siri and Norga, Koen},
article_location = {Oxford},
article_number = {December 2022},
doi = {http://dx.doi.org/10.1016/j.ejca.2022.09.025},
keywords = {European Paediatric regulation; Paediatric oncology drug development; Cancer therapeutics},
language = {eng},
issn = {0959-8049},
journal = {European Journal of Cancer},
title = {European regulatory strategy for supporting childhood cancer therapy developments},
url = {https://www.sciencedirect.com/science/article/pii/S0959804922007651?via%3Dihub},
volume = {177},
year = {2022}
}
TY - JOUR
ID - 2251415
AU - Karres, Dominik - Lesa, Giovanni - Ligas, Franca - Benchetrit, Sylvie - Galluzzo, Sara - Karen, Van Malderen - Štěrba, Jaroslav - Maaike, van Dartel - Renard, Marleen - Sisovsky, Peter - Wang, Siri - Norga, Koen
PY - 2022
TI - European regulatory strategy for supporting childhood cancer therapy developments
JF - European Journal of Cancer
VL - 177
IS - December 2022
SP - 25-29
EP - 25-29
PB - Elsevier Science Inc.
SN - 09598049
KW - European Paediatric regulation
KW - Paediatric oncology drug development
KW - Cancer therapeutics
UR - https://www.sciencedirect.com/science/article/pii/S0959804922007651?via%3Dihub
N2 - Introduction: Regulatory decisions on paediatric investigation plans (PIPs) aim at making effective and safe medicines timely available for children with high unmet medical need. At the same time, scientific knowledge progresses continuously leading frequently to the identification of new molecular targets in the therapeutic area of oncology. This, together with further efforts to optimise next generation medicines, results in novel innovative products in development pipelines. In the context of global regulatory development requirements for these growing pipelines of innovative products (e.g. US RACE for children Act), it is an increasing challenge to complete development efforts in paediatric oncology, a therapeutic area of rare and life-threatening diseases with high unmet needs.Objective: Regulators recognise feasibility challenges of the regulatory obligations in this context. Here, we explain the EU regulatory decision making strategy applied to paediatric oncology, which aims fostering evidence generation to support developments based on needs and robust science. Because there is a plethora of products under development within given classes of or within cancer types, priorities need to be identified and updated as evidence evolves. This also includes identifying the need for third or fourth generation products to secure focused and accelerated drug development.Conclusion: An agreed PIP, as a plan, is a living document which can be modified in light of new evidence. For this to be successful, input from the various relevant stakeholders, i.e. pa-tients/parents, clinicians and investigators is required. To efficiently obtain this input, the EMA is co-organising with ACCELERATE oncology stakeholder engagement platform meet-ings.
ER -
KARRES, Dominik, Giovanni LESA, Franca LIGAS, Sylvie BENCHETRIT, Sara GALLUZZO, Van Malderen KAREN, Jaroslav ŠTĚRBA, van Dartel MAAIKE, Marleen RENARD, Peter SISOVSKY, Siri WANG a Koen NORGA. European regulatory strategy for supporting childhood cancer therapy developments. \textit{European Journal of Cancer}. Oxford: Elsevier Science Inc., 2022, roč.~177, December 2022, s.~25-29. ISSN~0959-8049. Dostupné z: https://dx.doi.org/10.1016/j.ejca.2022.09.025.
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