FDA Issues Guidance on Male Inclusion in Breast Cancer Drugs

The FDA issued draft guidance urging sponsors of breast cancer treatments to include men in clinical trials.

The agency hopes to provide clarity on how to generate more data and include existing real-world data to better support drug development for male patients.

“The current lack of data means treatments for men are generally based upon studies and data collected in women,” noted Richard Pazdur, director of the FDA’s Oncology Center of Excellence.