Recommendations Guidance of Oncology Pharmaceuticals for Reproductive Toxicity in the USA and Europe

When fertility preservation for young cancer patients is conducted from an oncofertility perspective, anticancer treatment should be prioritized over any other therapies because the patient has cancer, unlike the case of usual therapy for infertility patients. Oncologists should inform cancer patients at an early stage of the possibility of gonadal dysfunction due to anticancer treatment and, in close collaboration with a doctor specialized in reproduction medicine, provide the opportunity to decide whether to receive fertility preservation. In recent years, due to advancements in oncology medicine and reproduction medicine, cancer patients who can preserve fertility before starting anticancer treatment have increased in number. Childhood, adolescent, and young adult (CAYA) cancer patients may be able to conceive within a short time following completion of anticancer treatment, depending on cancer status. Consequently, the question arises how soon after anticancer treatment completion can gestation be tried, given that the effects of anticancer chemotherapy and radiotherapy on gametes have been eliminated. In May 2019, to avoid the effects of drug use in patients with childbearing potential on the embryos/ fetuses or descendants, the American Food and Drug Administration(FDA)publishedOncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry.Subsequently, in February 2020, the European Medicines Agency(EMA)publishedResponse from SWP to CMDh questions regarding Genotoxicity and Contraception. In Japan, no corresponding guidance exists like USA and Europe. At present, the Research on Regulatory Science of Pharmaceuticals and Medical Devicesthe 2019‒2020 research panel for providing information regarding the appropriate use of drugs in patients with childbearing potential(the Japan Agency for Medical Research and Development)has been conducting research to develop guidance for contraception during drug use. The resulting guidance intends to contribute to enhancing awareness on the appropriate use of drugs during contraception. This panel has been compiling expert opinions for reproductive medicine, toxicology, and drug safety measures. This document is accompanied by explanations from the FDA guidance(2019)and EMA guidance(2020).