FDA Releases Draft Guidance on Inclusion of Males in Breast Cancer Trials



Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer. A statement from Richard Pazdur, M.D., 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Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, announcing the availability of a draft guidance, says that further data is usually needed to support labeling for breast cancer treatments for men.

The U.S. Food and Drug Administration’s (FDA) draft guidance recommends eligibility criteria for clinical trials on breast cancer treatments include both men and women, or to have a sound scientific reason for excluding men. To counteract the expected low accrual of men, it is suggested to extrapolate findings, if supported with available data. Additional data may be gathered through carefully developed trial designs, such as small single-arm studies, or from real-world data.

The goal of the draft guidance is to clarify how sponsors can collect data to support their investigational product’s safety and efficacy for male breast cancer patients, therefore increasing the number of FDA approved treatment options available to them.

Comment here now through October 28, 2019.


- The Clinical Pathways Team

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