ill Li, a breast pathologist at Emory University in Atlanta whose smaller 2017 study indicated that male breast cancer patients have worse outcomes than females, especially for early-stage disease.
To expand treatment options, the Food and Drug Administration issued a draft guidance in August encouraging drug companies to include men in breast cancer studies. (Last year, the FDA released a guidance document to motivate inclusion of pregnant women (SN: 5/30/18) in clinical trials.) And when clinical trial data is scant, the agency occasionally considers other sources of information. In April, for instance, the FDA expanded the indications for the breast cancer drug palbociclib to include men, based on electronic health records and post-marketing data related to patients’ real-world experiences.
Recently, the agency approved several breast cancer drugs for both men and women even though the clinical trials had no male participants, because the drugs weren’t expected to behave differently between genders, says Richard Pazdur, director of the FDA’s Oncology Center of Excellence.
“This is huge,” Singer says. This is “proof that the tide is turning, that we matter.”