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Use of juvenile animal studies to support oncology medicine development in children
1INFARMED, Lisboa, Portugal; LUSOFONA UNIVERSITY, School of Health Sciences and Technology, Lisboa, Portugal.
Abstract:
Childhood cancer has remained a challenge because of long-term effects in children. The need to extend access of children into new cancer therapies requires early prediction of specific safety aspects and juvenile animal studies (JAS) are being conducted to screen for age-related toxicities and differences occurring during postnatal development. This paper investigates oncology approved medicines in the EU (1995-2014) and PIP (Paediatric Investigation Plans - 2007-2014), regarding the usefulness of JAS in their non-clinical development by evaluating information on the medicines labelling. The retrospective review from medicines and PIPs revealed a steady use of JAS to better characterize safety: Approximately 1 in 3 oncology medicine or PIP has conducted JAS. For 6 of the cancer medicines with JAS the toxicity profile in adult and juvenile animals showed some differences in study findings. The discussion of these cases is illustrative of the potential significance that JAS have provided in oncology medicines.
Insights
Juvenile animal studies (JAS) are crucial for predicting childhood cancer drug safety. These studies revealed age-related toxicity differences, enhancing the characterization of oncology medicines for pediatric use.
Area of Science:
- Pediatric Oncology
- Toxicology
- Drug Development
Background:
- Childhood cancer presents long-term health challenges.
- New cancer therapies require early safety assessments in children.
- Juvenile animal studies (JAS) screen for age-related toxicities during development.
Purpose of the Study:
- To evaluate the utility of JAS in the non-clinical development of oncology medicines.
- To assess the use of JAS in European Union-approved oncology drugs (1995-2014) and Paediatric Investigation Plans (2007-2014).
Main Methods:
- Retrospective review of medicine labeling and Paediatric Investigation Plans.
- Analysis of information regarding the use and findings of JAS in oncology drug development.
Main Results:
- Approximately one-third of oncology medicines or PIPs included JAS.
- Differences in toxicity profiles between adult and juvenile animals were observed in 6 cancer medicines with JAS.
- JAS provided significant insights into the safety of oncology medicines.
Conclusions:
- JAS are consistently utilized to characterize the safety of pediatric oncology drugs.
- Findings from JAS highlight potential age-related safety differences, informing drug development.
- Juvenile animal studies are valuable for identifying specific safety aspects of cancer therapies in children.
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