FDA wants male breast cancer patients

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The FDA wants drugmakers to make men a regular part of breast cancer clinical trials. Regulatory Focus reports that the FDA is encouraging manufacturers to bring in male test patients “unless there is a valid scientific reason not to.”

RF says that although men comprise around 1% of breast cancer cases, the cancer has a “disproportionally negative effect on men.” One reason: men don't usually associate a lump with breast cancer, which means a later diagnosis and delayed treatment.

FDA's science lead also says men need to be part of breast cancer clinical trials because while postmenopausal women typically respond to aromatase inhibitors with tamoxifen as a second-line treatment, the reverse is true of male patients.

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