Abstract
Since oncology pharmaceuticals having developmental and/or genetic toxicity are occasionally administered to the pregnant and/or the reproductive potential patients for life-prolonging, it is important to consider those risks to patients and their next generations. Especially, with the increase of consciousness regarding the fertility preservation for cancer patients including Adolescent and Young Adult (AYA) generation, it has been required to reconsider appropriate education about the birth control and the risk communication between medical professionals and patients. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have published guidelines to minimize the potential risk of developmental and genetic toxicity associated with cancer treatments in reproductive potential patients. In Japan, a working group in Japan Agency for Medical Research and Development (AMED), set up for providing information on the proper use of pharmaceuticals in patients with reproductive potential, has prepared a Japanese guidance regarding the need of contraception in patients administered pharmaceuticals to minimize potential risks of developmental and genetic toxicities in their subsequent generations. On 16th of February, the guidance was finally published with its Q&A. In this presentation, we will give an outline of this guidance and introduce the viewpoints of reviewers based on some examples of the safety evaluation on pharmaceuticals having developmental and/or genetic toxicities.
