MHRA Grants Marketing Authorization for Eli Lilly’s Verzenios (abemaciclib) as First CDK4/6 Inhibitor for Adjuvant Treatment of High-Risk Early Breast Cancer

Compiled by Fan Dongdong

Recently, Eli Lilly's Verzenios (abemaciclib) has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA), approving Verzenios in combination with endocrine therapy for the adjuvant treatment of HR+, HER2-, high-risk lymph node-positive early breast cancer (EBC) patients.

Breast cancer is one of the most common cancers among women globally, with approximately 20% to 30% of patients diagnosed with HR+ or HER2- early-stage breast cancer, which may progress to incurable metastatic tumors in the future. Dr. Jeff Yang, Vice President of Medical at Eli Lilly's Nordic division, stated that this approval makes Verzenios the first CDK4/6 inhibitor authorized for the treatment of HR+, HER2-, high-risk early-stage breast cancer.

The MHRA approval was mainly based on the results of the Phase 3 monarchE trial, which met its primary endpoint. The Phase 3 monarchE trial involved 5,637 patients with HR+, HER2-, high-risk EBC from more than 38 countries. In the trial, Verzenios in combination with endocrine therapy reduced the risk of breast cancer recurrence by 32%.

As a CDK4/6 inhibitor, Verzenios can selectively inhibit cyclin-dependent kinases 4 and 6 (CDK4/6), restore cell cycle control, and block the proliferation of tumor cells. The drug was first approved for marketing in October 2017 for the treatment of HR+/HER2- advanced or metastatic breast cancer patients. CDK4/6 are key regulators of the cell cycle, capable of triggering the transition from the growth phase (G1 phase) to the DNA replication phase (S phase).

Last August, the NICE draft guidelines had already recommended Eli Lilly's Verzenios (abemaciclib), taken orally twice daily, for the treatment of adults with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the body. After being included in the UK's National Health Service (NHS), it is estimated that about 2,500 people will be eligible for treatment with Verzenios. (For more details, please click on "Eli Lilly's Breast Cancer Drug Verzenios Receives NICE Recommendation》）

In 2019, the total global breast cancer market reached $20.2 billion, with drugs targeting HER2 or CDK4/6 dominating (accounting for 68% of sales). The breast cancer market is projected to grow at an annual rate of 9% from 2019 to 2029, reaching $47.7 billion.

Currently, multiple CDK4/6 inhibitors have been launched globally, including Eli Lilly's Verzenio, Pfizer's Ibrance (palbociclib), and Novartis's Kisqali (ribociclib).

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MHRA marketing authorisation granted for Eli Lilly’s Verzenios as early breast cancer treatment