FDA’s Recent Approval of the Innovative New Early-Stage Breast Cancer Treatment

Abby Shapiro

The PV Student Publication has partnered with The Research Club to publish a series of research essays explaining innovative new research studies as well as other important topics. This essay explores the recently FDA approved treatment drug for early-stage breast cancer.

(Editors Note: The PV Student Publication has partnered with The Research Club to publish a series of research essays. All research essays are written and fact-checked by members of the Research Club, and The PV Student Publication is rolling out these essays as a service to our community. This article was intended to be released during Octobers’ breast cancer awareness month, but due to writing conflicts we are publishing the article in early November.)

On Oct. 12, the FDA [Food and Drug Administration], approved a new treatment therapy for early-stage breast cancer called Verzenio. Verzenio’s chemical name is abemaciclib. The specific type of breast cancer being treated by the drug is hormone-receptor-positive HER2-negative node-positive breast cancer that has a high risk of recurrence. Verenzio is a pill taken by mouth, given to patients after surgery. Therefore, it is considered an adjuvant treatment. 

 A kinase is a type of protein that helps in the process of ensuring cell division functions properly. Verzenio is a cyclin-dependent kinase inhibitor that stops the cancer cells from dividing and growing. 

Verzenio is used with other aromatase inhibitors-responsible for the stop of the production of estrogen- such as Arimidex, Aromasin, and Femara. The purpose of these inhibitors is to reduce the production of estrogen in the ovaries to decrease the growth of hormone-receptor-positive breast cancer cells. In advanced-stage breast cancer, Verzenio is used alone as the treatment if the cancer grows after chemotherapy.

Similar to most breast cancer medications, it is possible that Verzenio can cause side effects that can be severe. The most common side effect of Verzenio is diarrhea, which for most begins during the first week of treatment. When patients are prescribed Verzenio, doctors will prescribe an anti-diarrheal medicine. Some other common side effects are low white blood cell counts, fatigue, or infection. In more severe cases, side effects include liver problems, severely low white blood cell count, blood clots, or severe lung inflammation. 

The monarchE study enabled the approval of Verzenio as a treatment for early-stage breast cancer. The results concluded that with the addition of the drug to hormonal therapy after surgery, the risk of recurrence is lowered by about 25%. In addition, it lowered the risk of recurrence in parts of the body away from the breast. For example, the chances of cancer returning in the liver or brain by about 28%. Sara Tolaney, one of the researchers involved in the monarchE study, stated that she was encouraged by the marked reduction in the risk of recurrence. Sara Tolaney is eager to offer this as a treatment option to her patients. The new treatment therapy for post-surgery, Verzenio, will be a new option to consider for patients diagnosed with early-stage breast cancer with a high risk of recurrence. FDA’s approval could change the lives of many cancer patients thanks to the power of research.