Public consultation opens on standard paediatric investigation plans for two types of cancer in children
The European Medicines Agency has opened a public consultation on two standard paediatric investigation plans (PIPs) for two specific types of cancer with unmet medical needs in children, acute myeloid leukaemia and rhabdomyosarcoma.
A PIP sets out a programme for the development of a medicine to ultimately authorise its use in children. The goal of these standard PIPs is to support pharmaceutical companies to propose a plan that is scientifically adapted to the medicine.
These standard documents intend to propose plausible targets or mechanisms of action that could address the needs of these two particular types of cancer, set out the principal features of trials with children (and possibly young adults) suffering from these cancers and outline the possible requirements for a PIP for these conditions.
Compared to the progress made in other acute leukaemias, the outlook for children with myeloid leukaemia is still very poor and better treatments are needed.
Rhabdomyosarcoma occurs primarily in children and differs from other soft-tissue tumours affecting adults.
Standard PIPs are under development for other types of cancer with high unmet medical needs. The Agency's Paediatric Committee (PDCO) prepares these plans together with academic experts from paediatric oncology networks.
Comments on these documents should be submitted by 5 May 2013.
- Standard paediatric investigation plans
- Paediatric Committee
- Paediatric investigation plans, waivers and modifications
- Paediatric Regulation
- Five-year report to the European Commission on the experience acquired as a result of the application of the Paediatric Regulation