Oncologic Drugs Ovarian Toxicity Guidance

FDA has published a draft guidance, Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products, with recommendations to sponsors on measuring ovarian toxicity using clinical measures and biomarkers of ovarian function in relevant cancer clinical trials that enroll premenopausal women. The document says it specifically applies in the cancer setting where life expectancy based on tumor type is of a sufficient time where ovarian toxicities may be relevant.

“Ovarian toxicity should be considered as a safety endpoint in trials including premenopausal adults and should be considered an integral part of a drug development program when the intended therapy will be used in premenopausal women,” FDA says.

The guidance says recommendations about ovarian function in pediatric patients with cancer and nonclinical recommendations are outside the guidance’s scope and are not addressed.