FDA Draft Guidance Encourages Inclusion of Male Patients in Breast Cancer Clinical Trials
Posted: Tuesday, August 27, 2019
Yesterday, the U.S. Food and Drug Administration (FDA) released a Draft Guidance on “Male Breast Cancer: Developing Drugs for Treatment.” This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs and encourages the inclusion of male patients in breast cancer clinical trials. Historically, men either have not been included in clinical trials for drugs to treat breast cancer, or inclusion of men in those trials has been limited.
“When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a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, 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. “We hope that the recommendations in the draft guidance will, when finalized, encourage drug development for the treatment of male breast cancer and ultimately provide additional FDA-approved treatment options for patients.”