The US Food and Drug Administration’s (FDA) Research to Accelerate Cures and Equity (RACE) for Children Act now requires all oncology drugs to be tested for paediatric indications ahead of approval.
The EU regulation of the European Medicines Agency (EMA) is also being adapted to mirror the FDA’s regulations.
In response, Charles River Laboratories is giving clients access to the ITCC-P4 collection of 400 annotated paediatric cancer models to conduct preclinical cancer research.
“Globally, 400,000 children and adolescents develop cancer each year, and approximately one in four cannot be cured with currently available therapies,” said Aidan Synnott, Corporate Vice President, Global Discovery Services at Charles River.
“The ITCC-P4 collection is comprehensive, relevant, and well-characterised, meaning we can better assess the safety and efficacy of new oncology treatments specifically for children. This will ultimately lead to new treatment options for a critically important patient population.”
Paediatric tumours have different genomic drivers and phenotypes than adult tumours, requiring unique preclinical models. The ITCC-P4 collection is supported by an accompanying dataset consisting of molecular phenotyping and pharmacological characterisation.