The US Food and Drug Administration (FDA) has released new draft guidance encouraging drugmakers to enrol male patients in breast cancer clinical trials.

The FDA said that men account for less than 1% of breast cancer cases and have historically been excluded from breast cancer clinical trials.

According to the American Cancer Society, it is estimated that around 268,600 women will be diagnosed with breast cancer this year, compared to 2,670 men.

FDA Oncology Center of Excellence director Richard Pazdur said: “This has led to a lack of data, so their treatment is generally based on studies and data collected in women.”

“While some breast cancer treatments are approved for gender-neutral indications, many therapies are only approved for women and further data may be necessary to support labelling indications for men.”

The two-page draft guidance issued by FDA recommends sponsors and drugmakers to enrol both males and females in breast cancer clinical trials.

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It also suggests that extrapolation or additional data generation can be applied to support the breast cancer drugs and biologics used in male participants during a lack of clinical trial data.

The draft guidance encourages sponsors to discuss their clinical development plans for breast cancer therapies with the agency and stresses that clinical trial eligibility criteria should allow the inclusion of both genders.

The FDA also says that, without sufficient representation of men in breast cancer trials, data may be extrapolated in order to include men in the drug indications approved by the agency.

Extrapolation should be restricted to trials in case there is a concern about safety or efficacy between men and women based on the drug’s mechanism of action, the FDA added.