The Center for Drug Evaluation (CDE) has released a Technical Guidelines document focused on “Clinical R&D of Anti-tumor Drugs for Children.” The document is open for public feedback for a one-month period, aiming to gather insights and suggestions from stakeholders in the field of pediatric oncology.
Pediatric vs. Adult Anti-tumor Drugs
Compared with adult anti-tumor drugs, children’s anti-tumor drugs are relatively neglected as research and development targets. Significant discrepancies exist between child and adult tumors in terms of pathogenesis, tissue source, driving gene changes, and other factors. These differences ultimately lead to distinct disease types, symptoms, and treatment plans.
Document Highlights
The document defines pediatric cancer as a tumor occurring in children under 18 years of age. Unless otherwise specified, “children” in the document refers to adolescents under 18 years of age, including premature newborns, full-term newborns, infants, and children. The draft emphasizes that the development of pediatric indications for anti-tumor drugs is an important part of drug development and should not merely be considered “accessories” to adult anti-tumor drug development. However, it also acknowledges that pediatric drug development often needs to be supported by clinical data obtained from adult subjects. Therefore, the inclusion of pediatric indications in the overall clinical development plan (CDP) of drugs is encouraged.-Fineline Info & Tech
