August 26, 2019
2 min read
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FDA recommends inclusion of men in breast cancer drug trials

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Richard Pazdur, MD
Richard Padzur

The FDA today issued draft guidance for industry that calls for the inclusion of men as well as women in clinical trials of new breast cancer drugs, the agency announced.

“Less than 1% of all breast cancer cases occur in men, but men are more likely to be diagnosed at an older age and have a more advanced stage of disease,” Richard Padzur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “As breast cancer in men is rare, they have typically not been included in clinical trials for breast cancer treatment. This has led to a lack of data, so their treatment is generally based upon studies and data collected in women.”

The draft guidance, titled “Male Breast Cancer: Developing Drugs for Treatment,” outlines recommendations to clinical trial sponsors regarding the development and labeling of breast cancer drugs for the treatment of men with breast cancer.

The guidance suggests that eligibility criteria for breast cancer drug clinical trials permit the inclusion of both men and women, adding that trials excluding men should provide a scientific rationale for this exclusion in the protocol.

Additionally, if no men or only a very limited number have been included in a breast cancer trial, data may be extrapolated in order to include men in the FDA-approved drug indications. Such extrapolation should be restricted to trials in which no difference in safety or efficacy is expected between men and women, based on the drug’s mechanism of action. Extrapolation also should be backed by data from earlier stages of drug development, according to the recommendations. Concerns about differential effects between men and women may apply when the drug’s mechanism involves manipulation of the hormonal axis.

“[Although] some FDA-approved treatments are gender-neutral in their indication, many therapies are only approved for women, and further data may be necessary to support labeling indications for men,” Padzur said in the release. “Today we issued a draft guidance encouraging the inclusion of male patients in breast cancer clinical trials. When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a variety of trial designs using different sources, including studies using real-world data.”