The U.S. Food and Drug Administration (FDA) issued a draft guidance calling for the inclusion of male patients in clinical trials for breast cancer drugs.
The FDA said it encourages sponsors to discuss their breast cancer drug development plan early with the Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research when applicable. The agency also recommends that the eligibility criteria for clinical trials of breast cancer drugs should allow for inclusion of both males and females, and if men are excluded, there should be an explicit scientific rationale.
Lack of evidence for male breast cancer
“When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a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 data sources, including studies using real-world data,” said Richard Pazdur, MD, acting director of the FDA’s Office of Hematology and Oncology Products.
Men are not usually included in clinical trials for breast cancer treatment, which has led to a lack of data, and treatment for men is generally based on information from studies in women, according to the FDA. This exclusion has resulted in limited FDA-approved treatment options for men with breast cancer.
Less than 1% of all breast cancer cases occur in men.