FDA Approval for Verzenio™ as Initial Treatment for Advanced Breast Cancer

CancerConnect News: The U.S. Food and Drug Administration (FDA) has approved VerzenioTM (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.

About VerzenioTM

Verzenio is an inhibitor of cyclin-dependent kinases (CDK) 4 & 6.  A major hallmark of cancer cells is their ability to multiply rapidly; CDK inhibitors interfere with this process by blocking the activity of enzymes known as CDKs, particularly CDK 4 and CDK 6, that help to regulate cell division. For effectively treating breast cancer, CDK inhibitors are usually combined with endocrine therapy, which works by preventing hormones from binding with their respective receptors on the cancer cells.1

This approval of Verzenio as initial therapy in combination with an AI is based on the pivotal MONARCH 3 clinical trial. MONARCH 3 evaluated Verzenio in combination with an AI as initial endocrine-based therapy in 493 postmenopausal women with HR+, HER2- advanced breast cancer whom had no prior systemic treatment for advanced disease.2

Verzenio demonstrated a greater than 28-month median progression-free survival (PFS) in patients who received initial endocrine-based therapy for metastatic disease compared to 14.8 months for treatment with an AI alone. Verzenio plus an AI had an objective response rate of 55.4 percent compared to 40.2 percent for treatment with an AI alone. The median duration of response was 27.4 months with Verzenio plus an AI versus 17.5 months for treatment with an AI alone.2

Verzenio is now indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:

  • in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy
  • in combination with fulvestrant for women with disease progression following endocrine therapy
  • as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting

“For those facing a diagnosis of metastatic breast cancer or learning that their disease has spread further, each new indication and clinical development is critical,” said Marc Hurlbert, Ph.D., chairman, Metastatic Breast Cancer Alliance. “Today’s news represents continued progress towards helping more people living with this devastating disease.”


  1. Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.
  2. Patnaik A, Rosen LS, Tolaney SM, et al. Efficacy and safety of abemaciclib, an inhibitor of CDK4 and CDK6, for patients with breast cancer, non-small cell lung cancer, and other solid tumors [published ahead of print May 23, 2016]. Cancer Discov. 2016;6:740-753.

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