The Impact of FDA’s Guidance on Mammography Quality Standards Act: Q&A with Steven C. Quay

Steven C. Quay, M.D., PH.D.
Chairman & CEO
Atossa Therapeutics

FDA recently issued draft guidance that states that doctors should inform women receiving breast exams whether or not they have thick breast tissue. This information hasn’t always been provided to patients, despite its potential for medical impact. Atossa Therapeutics’ CEO Dr. Steven C. Quay, MD, PhD, spoke with Pharmaceutical Executive about this update and the impact it may have.

Pharmaceutical Executive: What is the significance of FDA’s new guidelines regarding the Mammography Quality Standards Act?
Dr. Steven C. Quay: The implementation of the breast density notification update is commendable and paves the way for better detection and diagnosis. The new requirements lay the groundwork for guiding patients and physicians in managing dense breast tissue, especially concerning Estrogen Receptor-positive (ER+) breast cancers, where density plays a critical role in risk assessment.

PE: How many women have dense breast tissue and are unaware of it and the significance?
Quay: It is estimated that 50% of women have dense breasts, so the number impacted by the new mammography standards is truly substantial. Moreover, approximately 39 million mammograms are performed each year, and in that year, about 10 million are going to get a report that they have high density.

Elevated density is a significant independent risk factor for developing breast cancer, and elevated density makes mammograms less effective. Vitally, missed or delayed tumor diagnosis can occur in women with dense breast tissue.

PE: How important is the development of treatments to reduce breast density?
Quay: Right now, women get their mammogram yearly or every two years. Before this update, a woman simply is told, you have a lesion and must come back for further analysis and treatment, or you’re fine. The additional information brought on by this update, will inform them that they have low, intermediate, or high density, which can trigger some additional imaging. I should note that this additional imaging, be it MRI or sonogram, could be extremely complicated for some women in terms of additional costs, insurance coverage, scheduling, etc., and of course, this triggers a real emotional toll, a daunting and terrifying experience for these women and their loved ones. So this is why, moving forward, it will be immensely helpful to have a treatment that can address that—so the oncologists can inform the patient, “You have high density, which means there is an increased risk of cancer, but there’s also an option, that if you take this treatment for some time, maybe 6 months, you can lower your density, make detecting any abnormalities easier, and also lower your incidence of cancer,” which could be very beneficial.

PE: What products does Atossa have in development/trials to address this?
Quay: Atossa is currently evaluating its lead asset, (Z)-endoxifen, in multiple phase 2 clinical trials, including the Karisma-Endoxifen study, which is investigating the potential for (Z)-endoxifen to reduce mammographic breast density in premenopausal women with measurable density. Data from the trial is expected prior to year-end 2024. Currently, there are no approved treatments to reduce breast density.

Atossa is also proudly supporting the SMART (Stockholm MAmmography Risk stratified Trial) study, a recently announced phase 2 study designed to validate an innovative, artificial intelligence driven, breast cancer risk assessment model. The study will test an individualized, imaging-based screening model designed to identify women with the highest risk of developing breast cancer in the next two years. If the model is validated for therapeutic use, it could serve as the foundation for a future, phase 3, trial investigating (Z)-endoxifen in the breast cancer prevention setting.