The FDA released a draft guidance for cancer drug developers on submitting initial pediatric study plans (iPSPs) after new requirements go into effect on August 18.
Section 504 of the FDA Reauthorization Act of 2017 required pediatric investigations of certain targeted cancer drugs with new active ingredients based on the molecular mechanism of action rather than clinical indication. The changes are aimed at encouraging the development of pediatric therapies.
After August 18, sponsors must submit iPSPs for original new active ingredient applications regardless of the drug’s proposed adult cancer indication or if it is for an indication that has been granted orphan designation, the agency said, adding that the study plans should address the drug’s molecular target and its relevance to one or more cancers in the pediatric population.
The iPSPs will also be necessary for supplemental applications for a new indication, new dosage form, new dosing regimen, or new route of administration, unless the drug is for an indication with orphan status, the agency said.