FDA Announces Draft Guidance for Developing Drugs for Male Breast Cancer

FDA Announces Draft Guidance for Developing Drugs for Male Breast Cancer

The U.S. Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled, “Male Breast Cancer: Developing Drugs for Treatment.” This draft guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, for the treatment of male patients with breast cancer. Males have historically been excluded from clinical trials of breast cancer drugs because breast cancer in males is rare. As a result, there are limited FDA-approved treatment options specifically approved for males with breast cancer. The draft guidance recommends inclusion of males and females in clinical trials of breast cancer drugs and recommends that scientific rationale be included in the protocol if males are excluded. The draft guidance also suggests that in certain situations, the FDA can extrapolate findings to include males in the drug’s indication when no males or only a limited number of males have been included in the clinical trial. In other situations, the guidance details that additional supportive data from males may be needed. The FDA seeks comments and suggestions on this guidance. For more information, please refer to the guidance. Find additional information at: Draft guidance for industry titled, “Male Breast Cancer: Developing Drugs for Treatment” FDA in Brief: FDA encourages inclusion of male patients in breast cancer clinical trials