FDA is looking ahead of industry in its guideline on targets for pediatric oncology, which includes more than 50 not yet in company pipelines in a list of over 220 the agency has its eye on. The list details molecular targets that could trigger a requirement to conduct pediatric trials, and suggests the agency sees potential in unexploited territory, in particular in gene regulation.
The list was published Oct. 16, following a series of discussions with National Cancer Institute and other stakeholders, including a February workshop hosted by Friends of Cancer Research, which identified molecular targets or groups of targets that had been linked to pediatric cancers in published papers or company development programs.
The guidelines are part of a push by FDA and regulators worldwide to accelerate pediatric drug development, which typically lags years behind development of drugs for similar adult indications (see “Pediatric Push”).
In oncology, the problem has been exacerbated by the Pediatric Research Equity Act (PREA), because it exempts Orphan diseases -- which include all pediatric cancers -- from