National Center for Health Research, October 28, 2019
National Center for Health Research’s Public Comments on the FDA’s
Male Breast Cancer: Developing Drugs for Treatment; Draft Guidance for Industry
Thank you for the opportunity to express our views on the Food and Drug Administration (FDA) draft guidance for industry on the development of drugs for male breast cancer treatment. The National Center for Health Research is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
Increased diversity and inclusion in clinical trials are important, and we agree with the FDA guidance that male patients with breast cancer should be included in clinical trials. Male patients comprise only 1% of breast cancer patients and have largely been excluded from clinical trials. As a result, most men with breast cancer receive treatments tested only or almost only on women. This is particularly noteworthy because male patients have a 19% higher mortality rate compared to female breast cancer patients, which may suggest that what works for women may not work as well for men.1
The fact that FDA-approved treatment options are usually not indicated for or tested on male breast cancer patients is problematic. Extrapolation of expected benefit and risk from females to males may not be accurate because differences between sexes may impact the efficacy and safety of drugs. Males are treated with the same drugs as female patients, whether or not the drugs are tested on and indicated for men.
Drug labels and indications should therefore clearly identify the populations on which drugs have been studied, including any outcome differences associated with sex by race/ethnicity and age, as well as which demographic subgroups are most likely to benefit. In addition, it is essential that well-designed clinical trials determine how demographic differences affect safety and efficacy, so that clinicians and their patients can make informed decisions about which treatment options are the most appropriate.
This recommendation for sponsors regarding the development and labeling of cancer drugs for male patients with breast cancer is, therefore, a step in the right direction. We look forward to additional efforts to increase inclusion and study of patients underrepresented or excluded from clinical trials for various conditions.
For questions or more information, please contact Stephanie Fox-Rawlings, PhD at the National Center for Health Research at sfr@center4research.org or at (202) 223-4000.
Reference:
- Wang F, Shu X, Meszoely I, et al. Overall Mortality After Diagnosis of Breast Cancer in Men vs Women. JAMA Oncology. Published online September 19, 2019. https://jamanetwork.com/journals/jamaoncology/article-abstract/2751525