Drugs

Oncology Drug Reproductive Toxicity Testing Guidance

FDA has issued a guidance, Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, to assist sponsors in evaluating reproductive toxicity (mainly for effects on embryo-fetal development, or EFD) for oncology pharmaceuticals. The document also is intended to provide recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk to a developing embryo or fetus.

Concepts discussed in the guidance are:

evaluation of EFD toxicity for various types of pharmaceuticals;
evaluation of EFD toxicity for pharmaceuticals intended for specific populations;
use of available information, such as the results of genotoxicity and general toxicity studies, knowledge of target biology, and available data on genetically modified animals in assessing the need for a dedicated EFD study; and
labeling recommendations for duration of contraception in male and female patients to minimize risk to a developing embryo or fetus.

The guidance does not address risks of reproductive toxicity from radiopharmaceuticals, cellular and gene therapy products, cancer vaccines, biosimilar or interchangeable products, or generic drugs. And it does not address margins of safety by systemic exposure or dose. Finally, it does not address the potential risks to a developing embryo or fetus during clinical trials because pregnancy testing and use of highly effective methods of birth control are usually adequate to minimize the risk of unintentional exposure of the embryo or fetus when including women of reproductive potential in clinical trials.

Contents of the guidance are: Introduction, Assessment of Enbryo-Fetal Developmental Toxicity, Assessment of Fertility, Assessment of Pre- and Postnatal Developmental Effects, Assessment of Risk for Specific Populations, Recommendations on Contraception, and References.

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