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The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.
FDA released guidance in August 2020 on the development and labeling of treatments for male patients with breast cancer. According to FDA, due to the rare nature of breast cancer in males, they have been excluded from clinical trials of breast cancer drugs.
The guidance recommends that both males and females should be included in eligibility criteria for clinical trials. “FDA does not intend to consider low expected accrual rates of male patients with breast cancer to be a sufficient scientific rationale for excluding them from a clinical trial,” the guidance states. In addition, the guidance states, “sponsors should conduct nonclinical general toxicology studies in male and female animals” when males are included in clinical trials for breast cancer treatments.