FDA Urges Inclusion of Men in Clinical Trials for Breast Cancer Treatment

FDA Urges Inclusion of Men in Clinical Trials for Breast Cancer Treatment
The U.S. Food and Drug Administration (FDA) has drafted a series of recommendations urging the inclusion of men in breast cancer clinical trials, aiming to broaden treatment options for these patients. Men are rarely included in clinical trials assessing the effectiveness of medications to treat breast cancer because the incidence of this particular type of cancer in males is extremely low. However, by the time it is diagnosed, breast cancer in men is usually more advanced, and there are few treatment options. The "Draft Guidance for Industry: Male Breast Cancer: Developing Drugs for Treatment," is available here. Comments on the draft guidance may be submitted online using the link available here. To ensure the FDA considers your comment before it begins work on the final version of the guidance, submit either online or written comments before the Oct. 26 close date. Written comments may be mailed to: Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852. All written comments should be identified with the docket number FDA-2019-D-2966. "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 disease," Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products (OHOP) in the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release. "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," Pazdur added. This pose
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