FDA Approves Drug for Certain Advanced or Metastatic Breast Cancers

Officials with the FDA have approved abemaciclib (Verzenio, Eli Lilly), for the treatment of adults with certain advanced or metastatic breast cancer. The drug is indicated for patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.

The drug is approved to be given in combination with an endocrine therapy, called fulvestrant. It can also be given as a stand-alone therapy, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread.

The approval is based on a clinical trial of 669 patients with HR+/HER2- breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized. Progression-free survival was measured as the length of time tumors did not grow after treatment. Patients who took Verzenio with fulvestrant’s median progression-free survival was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant.

Palbociclib, approved in February 2015, and ribociclib, approved in March 2017, are the 2 other drugs in this class that are indicated for certain patients with breast cancer. Verzenio is the only drug in the class that can be given alone as a treatment to patients who were previously treated with endocrine therapy and chemotherapy.

Common adverse effects of Verzenio include diarrhea, low levels of certain white blood cells, nausea, abdominal pain, infections, fatigue, low levels of red blood cells, decreased appetite, vomiting, and headache.

Reference

FDA approves new treatment for certain advanced or metastatic breast cancers [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm. Accessed September 28, 2017

For more on what roles pharmacists can play in treating patients with cancer, watch the video below from Specialty Pharmacy Times.