FDA may finalize requirement to include males in breast cancer trials 

The FDA may soon be finalizing a proposed rule that would require those developing breast cancer drugs to include males in the clinical trials. Back in August, the agency published a guidance document outlining the new rule — it was then subject to a 60-day comment period, which ended over the weekend. As currently written, the rule would require drug developers to account for the inclusion of both men and women in clinical trials and to provide a scientific rationale if they were planning on excluding men. The agency also stated that it did not think low recruitment numbers were a proper reason for excluding males. Only 1% of breast cancer patients are male, which explains why they’ve been historically left out of trials, but new research also suggests that these patients have a higher mortality rate than women.