FDA issue draft guidance for developing drugs for male breast cancer

The US Food and Drug Administration yesterday announcing the availability of a draft guidance for industry titled, “Male Breast Cancer: Developing Drugs for Treatment."

This draft guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, for the treatment of male patients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The draft guidance recommends inclusion of males and females in clinical trials of breast cancer drugs and recommends that scientific rationale be included in the protocol if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.