Is the European Pediatric Medicine Regulation working for children and adolescents with cancer?
Authors: Vassal G, Geoerger B, Morland B
Abstract
The European Pediatric Medicine Regulation was launched in 2007 to provide better medicines for children. Five years later, the number of new anticancer drugs in early development in the pediatric population remains low and most children with cancer are still largely denied access to innovative drugs in Europe, as compared to the US. We analyzed individual PIP and waiver decisions for oncology drugs as well as all oncology drugs which have been approved for marketing authorization since 2007 in Europe. Among the 45 approved Pediatric Investigation Plans (PIPs), 33% concern leukemias and lymphomas, 29% solid tumors, 13% brain tumors and 20% a drug for supportive care. There is no specific PIP for life-threatening diseases such as hig...
