Include men in breast cancer trials: US FDA

November 15, 2019 0 By FM

The USFDA has stressed the inclusion of male patients in the clinical trials of breast cancer, in a recently released draft guidance, Male Breast Cancer: Developing Drugs for Treatment.

“Less than one percent of all breast cancer cases occur in men, but men are more likely to be diagnosed at an older age and have a more advanced stage of the disease. As breast cancer in men is rare, they have typically not been included in clinical trials for breast cancer treatment. This has led to a lack of data, so their treatment is generally based upon studies and data collected in women.

While some FDA-approved treatments are gender-neutral in their indication, many therapies are only approved for women and further
data may be necessary to support labelling indications for men,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a press release.

When finalized, the recommendations in the draft guidance will provide clarity for industry regarding how additional data to support efficacy and safety for male patients with breast cancer can be generated through a variety of trial designs using different data sources, including studies using real-world data,” he continued.

 “We hope that the recommendations in the draft guidance issued today will, when finalized, encourage drug development for the treatment of male breast cancer and ultimately, provide additional FDA-approved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

Historically, males either have not been included in clinical trials for drugs to treat breast cancer or their inclusion has been very limited.