FDA Approves Verzenio for Advanced or Metastatic Breast Cancer

Verzenio is an inhibitor of cyclin-dependent kinases 4 and 6
Verzenio is an inhibitor of cyclin-dependent kinases 4 and 6

The Food and Drug Administration (FDA) has approved Verzenio (abemaciclib; Lilly) for the treatment of certain advanced and metastatic breast cancers.

Specifically, Verzenio is indicated in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

It is also indicated as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

"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 Richard Pazdur, M.D., 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.

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Verzenio is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), molecules involved in promoting the growth of cancer cells. In breast cancer xenograft models, abemaciclib dosed daily without interruption as a single agent or in combination with antiestrogens resulted in reduction of tumor size. Other FDA-approved agents that belong to the same class include palbociclib and ribociclib, both approved for the treatment of breast cancer.

The approval of Verzenio was based on results from two clinical trials. One study assessed Verzenio in combination with fulvestrant in 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 (n=669). The median progression-free survival for patients who received the combination was 16.4 months compared to 9.3 months for those who received placebo + fulvestrant.

In a second trial, Verzenio was evaluated as a stand-alone treatment in patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized (n=132). In this study, 19.7% of patients treated with Verzenio saw a complete or partial shrinkage of their tumors for a median of 8.6 months.

The most common adverse effects of therapy include diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting headache, and thrombocytopenia. In clinical trials, diarrhea occurred in 86% of patients receiving Verzenio + fulvestrant and 90% of patients receiving Verzenio alone.

Verzenio will be available in 50mg, 100mg, 150mg, and 200mg tablet strengths. 

For more information visit Lilly.com.