iPSP Considerations For Molecularly Targeted Cancer Drugs

By Olga Momcilovic

With the passage of the Pediatric Research Equity Act (PREA) of 2003, drug manufacturers were required to submit an initial pediatric study plan (iPSP) prior to commencement of Phase 3 studies (or new drug application [NDA]/biologics license application [BLA] submission in the absence of a Phase 3 study) for studies involving a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration. The iPSP is expected to contain an assessment of safety and effectiveness of the investigational drug for the proposed indication in all relevant pediatric subpopulations. In certain situations, a deferral or waiver for conducting pediatric studies can be obtained.