Developing Male Breast Cancer Drugs

FDA has issued a guidance, Male Breast Cancer: Developing Drugs for Treatment, with recommendations for sponsors on the development and labeling of cancer drugs, including biological products, regulated by CDER and CBER for treating male patients with breast cancer. The document says the historic exclusion of males from breast cancer drug clinical trials has resulted in limited FDA-approved treatment options. Clinical management of male breast cancer is generally based on clinical experience with breast cancer in females and data from studies conducted in females with breast cancer, it says.

The guidance says the agency encourages sponsors to discuss their breast cancer drug development plan early in development with the applicable Center. Such discussions, it says, may include expectations related to the number of male patients and data in male patients for specific development programs.