FDA has issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal drug and biological products.
When finalized, the guidance will provide recommendations for industry to generate additional data that will support the efficacy and safety of drugs and biologics for premenopausal women with breast cancer.
Historically, premenopausal women have been excluded from clinical trials that investigated the efficacy of hormonal drugs for the treatment of hormone positive breast cancer, largely due to concerns about potential differences in how these hormonal drug and biological products would behave in premenopausal versus postmenopausal women. This exclusion resulted in delays in availability of these therapies for premenopausal women.
“We believe that with sufficient estrogen suppression, hormonal drug and biological products are likely to have similar efficacy and safety in premenopausal women as in postmenopausal women. Therefore, premenopausal women should be included in these clinical trials,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“Once finalized, we hope that the recommendations in the draft guidance will encourage expanded drug development for the treatment of breast cancer in premenopausal women,” he said.
