The US Food and Drug Administration (FDA) is proposing sponsors collect ovarian toxicity data during cancer drug development. The agency said that cancer drugs may be associated with infertility and certain other morbidities including early onsite menopause and earlier onset cardiovascular disease, and there is a lack of data that may affect patients after they are treated.
On 26 November, FDA published draft guidance for cancer drug sponsors on collecting data on clinical measures and biomarkers for premenopausal adults that may suffer from infertility and morbidities due to the drug. More specifically, the guidance stated that ovarian toxicity should be considered a safety endpoint in trials that include premenopausal adults and should be an integral part of the drug development considerations when the drug is intended for premenopausal patients…
