FDA approves Verzenio for metastatic breast cancer

The U.S. Food and Drug Administration has approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).

“Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” said Dr Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Verzenio works by cyclin-dependent kinases 4 and 6, involved in promoting the growth of cancer cells.

There are two other drugs in this class that are approved for certain patients with breast cancer, palbociclib approved in February 2015 and ribociclib approved in March 2017.

The safety and efficacy of Verzenio in combination with fulvestrant were studied in a randomised trial of 669 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasised.

The study measured the length of time tumours did not grow after treatment (progression-free survival). The median progression-free survival for patients taking Verzenio with fulvestrant was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant.

The safety and efficacy of Verzenio as a stand-alone treatment were studied in a single-arm trial of 132 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasised.

The study also measured the percent of patients whose tumours completely or partially shrank after treatment (objective response rate). In the study, 19.7 percent of patients taking Verzenio experienced complete or partial shrinkage of their tumours for a median 8.6 months.

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

Serious side effects of Verzenio include diarrhoea, neutropenia, elevated liver blood tests and blood clots. Women who are pregnant should not take Verzenio because it may cause harm to a developing fetus.

The FDA granted this application Priority Review and Breakthrough Therapy designation. 

The FDA granted the approval of Verzenio to Eli Lilly and Company.