Abemaciclib Receives FDA Breakthrough Therapy Designation in Advanced Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to abemaciclib, a cyclin-dependent kinase (CDK) 4 and 6 inhibitor, for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

According to the FDA, Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.1 In the U.S. each year, nearly 232,000 individuals will develop invasive breast cancer and about 40,000 women will succumb to their disease.2 Of all diagnosed breast cancer cases in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.1 Metastatic breast cancer is rarely curable, but is often treatable and controllable for many years.

About Abemaciclib
Abemaciclib is a cyclin-dependant kinase. Cyclin-dependent kinases play a key role in regulating the replication and growth of cells. In many cancers, uncontrolled cell growth occurs because there is a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and 6. Abemaciclib was designed to block the growth of cancer cells by specifically inhibiting CDK 4 and 6. Although abemaciclib inhibits both CDK 4 and CDK 6.

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Abemaciclib is being developed by Lilly Oncology which has an active clinical development program studying abemaciclib in breast cancer. MONARCH 1 is a Phase II clinical trial evaluating the use of abemaciclib as single therapy in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. In addition, Lilly is evaluating abemaciclib in two Phase III clinical trials: MONARCH 2 to evaluate the combination of abemaciclib and fulvestrant in postmenopausal patients with HR+, HER2- advanced or metastatic breast cancer, and MONARCH 3 to evaluate the combination of abemaciclib and a nonsteroidal aromatase inhibitor in patients with HR+, HER2- locoregionally recurrent or metastatic breast cancer.


  1. American Cancer Society, “What are the key statistics about breast cancer?”, http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics. Accessed: August 18, 2015.
  2. Metastatic Breast Cancer Network, “13 Facts about Metastatic Breast Cancer”, http://mbcn.org/developing-awareness/category/13-things-everyone-should-know-about-metastatic-breast-cancer. Accessed August 18, 2015.
  3. World Cancer Research Fund International, “Breast Cancer”, http://www.wcrf.org/cancer_statistics/data_specific_cancers/breast_cancer_statistics.php. Accessed: August 18, 2015.

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