28 August 2019 - Men with breast cancer make up less than one percent of all breast cancer cases, but they are more likely than women to be diagnosed at a later stage of disease and at an older age, which can make treating the cancer more challenging.

However, because the disease is relatively rare in men, they are often excluded from clinical trials to explore new treatments. Now a new document released by the FDA is urging companies to change this and include men in their trials.

"Today we issued a draft guidance encouraging the inclusion of male patients in breast cancer clinical trials," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence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. "When finalised, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a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," he added.

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