WASHINGTON — The Food and Drug Administration is pushing drug companies to include younger people in drug trials for breast cancer drugs — a boon for the more than 16,000 American women under the age of 40 who are diagnosed with the condition each year.
The FDA’s new guidance, published in draft form earlier this month, encourages drug companies that are investigating hormonal treatments for breast cancer to include people who are premenopausal in the drug trials, provided they take adequate hormone-suppressing drugs. Until now, they had often been excluded from such studies, in part because drug companies worried their fluctuating hormones, which are different from those expressed by individuals who are post-menopausal, could affect the efficacy of the drug or even skew results.
The proposed recommendations, which are not legal requirements, come amid a broader effort at the agency to expand clinical trial access to younger and more seriously ill cancer patients, such as those with recurrent tumors and brain metastases.
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