The recent first global approval of abemaciclib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

In September, 2017 Abemaciclib (Verzenio™), developed by Ely Lilly and Company, received its first global approval in the USA, for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting[3]. Abemaciclib is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6); these, in combination with cyclin D are key drivers of cell proliferation, and are therefore effective targets for cancer treatment.

The FDA granted priority review and Breakthrough Therapy Designation to abemaciclib and approval was granted almost three months before its due date[3]. The approval of abemaciclib monotherapy was based on results from the phase II MONARCH-1 trial, and the combination therapy on results from the phase III MONARCH-2 trial[4].

Alarmingly, more than 40,600 women are predicted to die from breast cancer in 2017. Breast cancer is not limited to females, almost 2,500 new cases of invasive breast cancer are expected in men during the same year; although this is still overshadowed by the estimated 25,2710 new cases in women[5].

Abemaciclib is described as “the only CDK4 & 6 inhibitor approved with a continuous dosing schedule.” Patients are expected to continue the medication until unacceptable toxicity or disease progression [6]  Diarrhoea, Neutropenia, hepatotoxicity, venous thromboembolism and embryo-fetal toxicity were reactions noted in the warnings and precaution section of the prescribing information[7].

“In recent years, CDK4 & 6 inhibitors have evolved treatment expectations for those with metastatic breast cancer,” stated George W Sledge Jr., M.D., professor of medicine, Stanford University School of Medicine and principal investigator of the MONARCH 2 trial. He went on to explain that, This approval “represents an important development for our patients, who are dealing with the uncertainty of breast cancer progression.” [6]

His sentiments were reiterated by Marc Hurlbert, Ph.D., chairman, Metastatic Breast Cancer Alliance, who commented that “For women living with advanced disease, every new treatment approved offers the hope of possibility – that their oncologists have more options that may help slow the spread of this deadly cancer.” [6]

Abemaciclib is awaiting approval in Japan and EU for the treatment of breast cancer. Late stage clinical development is underway worldwide for the treatment of breast cancer and non-small cell lung cancer[2].

For further information related to the first approval of abemaciclib please visit Drugs[1],  or to learn more about the overall development of abemaciclib across all indications visit AdisInsight[2].

Credit: Catlane/ Getty Images/ iStoc

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