FDA Approves Abemaciclib for Treatment of Breast Cancers That Progress With Endocrine Therapy
Posted: Monday, October 2, 2017
On September 28, the U.S Food and Drug Administration (FDA) approved Verzenio (abemaciclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.
Abemaciclib, which works by blocking cyclin-dependent kinases 4 and 6, has been approved to be given in junction with fulvestrant after the cancer has continued to grow post-endocrine treatment. It has also been approved to be administered on its own, but only after the patient has been formerly treated with endocrine therapy and chemotherapy after the cancer has metastasized.
The combination therapy approval is based on a randomized 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 metastasized. The median progression-free survival for patients taking abemaciclib with fulvestrant was 16.4 months compared with 9.3 months for patients taking a placebo with fulvestrant.
The stand-alone treatment approval is based on 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 metastasized. In this study, 19.7% of patients taking abemaciclib experienced complete or partial shrinkage of their tumors for a median 8.6 months.
Common side effects of abemaciclib include diarrhea, neutropenia and leukopenia, nausea, abdominal pain, infections, fatigue, anemia, decreased appetite, vomiting, and headache.