USA – Evaluating Reproductive Toxicity in Oncology Drugs: FDA Finalizes Guidance

The US Food and Drug Administration (FDA) on Thursday finalized guidance to help sponsors of oncology drugs evaluate reproductive toxicity, with recommendations for labeling on duration of contraception following cessation of therapy.

The 10-page guidance finalizes a draft from September 2017 and is meant to complement ICH’s S9 guideline on Nonclinical Evaluation for Anticancer Pharmaceuticals and a question and answer document on S9.

The guidance deals with evaluating embryo-fetal development (EFD) and assessing the need for an EFD study with a weight of evidence (WOE) approach, which is further explained in detail in the guidance.

“For small molecules, EFD studies, when needed, are typically conducted in two species; and when the study is positive for teratogenicity or embryo-fetal lethality in one species, generally a study in the second species is not warranted,” the guidance says…