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US FDA to encourage inclusion of male patients in breast cancer drug trials

The U.S. Food and Drug Administration said men with breast cancer should be included in breast cancer drug trials, citing the lack of existing data in a newly released draft guidance for industry.

The draft guidance, published Aug. 26, noted that the FDA will expect drug developers to provide scientific rationale when prospective clinical trials for breast cancer exclude male patients and that "low expected accrual rates of male patients with breast cancer" will not be a sufficient reason.

If male participation in breast cancer trials is limited or nonexistent, drug developers may be able to extrapolate their findings using early drug testing and other existing literature. In cases where further data is required, the FDA's draft guidance encouraged real-world data sources and single-arm trials.

Men make up less than 1% of all breast cancer cases, according to Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products. Men are typically diagnosed later, with a more advanced stage of the disease, Pazdur stated in the FDA's accompanying press release.

Male breast cancer treatments are similar to female breast cancer treatments, including mastectomy, hormone therapies, chemotherapy and radiation, but the treatment of males with breast cancer is typically based on clinical experience with female patients rather than clinical trial evidence, the FDA's draft guidance said.

Pazdur said while some breast cancer drugs are approved regardless of gender, many therapies are approved only for women with breast cancer.

Pharma giant Pfizer Inc. expanded its breast cancer drug Ibrance's label in April 2019 to include male breast cancer patients based on electronic health record data and post-marketing real-world evidence studies. Along with Novartis AG's Piqray, approved in May 2019 on the basis of studies in both men and women, Ibrance is one of the only breast cancer drugs to gain approval specifically for men.

"We hope that the recommendations in the draft guidance issued today will, when finalized, encourage drug development for the treatment of male breast cancer and ultimately, provide additional FDA-approved treatment options for patients," Pazdur concluded.