Premenopausal Women with Breast Cancer: Developing Drugs for Treatment

On 7 October 2020 the FDA announced the availability of the draft guidance for industry. Comments may be submitted until 7 December 2020.

This guidance provides recommendations to sponsors developing drugs or biological products regulated by CDER and CBER for the treatment of breast cancer. Specifically, this guidance includes recommendations regarding the inclusion of premenopausal women, as defined by serum hormonal levels (including but not limited to follicle-stimulating hormone and estradiol), in breast cancer clinical trials. The issues of fertility and fertility preservation when treating premenopausal women with breast cancer are outside the scope of this guidance and are not addressed.