MHRA Approves Verzenios for Certain Types of Early Breast Cancer
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to Eli Lilly’s Verzenios (abemaciclib) in combination with endocrine therapy for adjuvant treatment of patients with early breast cancer.
The specific indication is for early breast cancer patients who are hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive and at high risk of disease recurrence.
The approval was based on a 5,637-participant study that achieved its primary endpoint of invasive disease-free survival.
Verzenios is authorized in the EU for HR-positive, HER2-negative early breast cancer and for metastatic breast cancer but only if combined with a hormonal medicine, an aromatase inhibitor or a fulvestrant. The kinase inhibitor, sold as Verzenio, is also approved in the U.S. for similar indications.
Abemaciclib (trade names Verzenio, Verzenios and Ramiven) is a drug for the treatment of advanced or metastatic breast cancers. It was developed by Eli Lilly and it acts as a CDK inhibitor selective for CDK4 and CDK6. It was designated as a breakthrough therapy for breast cancer by the U.S. Food and Drug Administration (FDA) in October 2015. On 28 September 2017, it was approved for use in the United States by the FDA for the treatment of certain breast cancers.
May 18, 2022
