Eli Lilly's CDK4/6 inhibitor Verzenios gets MHRA approval for early breast cancer

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

Breast cancer is one of the most common cancers in women worldwi.

The MHRA approval was based primarily on results from the Phase 3 monarchE trial, which met its primary endpoi.

As a CDK4/6 inhibitor, Verzenios selectively inhibits cyclin-dependent kinase 4/6 (CDK4/6), restoring cell cycle control and blocking tumor cell proliferati.

Last August, draft NICE guidelines recommended Eli Lilly's twice-daily oral Verzenios (abemaciclib) for the treatment of adults with hormone receptor-positive, HER2-negative breast cancer that has spread to other parts of the bo.

In 2019, the total global breast cancer market reached US$22 billion, with drugs targeting HER2 or CDK4/6 dominated (68% of sales), and the breast cancer market is expected to grow by 9% annually from 2019 to 2029 , reaching $47 billi.

At present, a number of CDK4/6 inhibitors have been launched worldwide, in addition to Eli Lilly's Verzenio, Pfizer's Ibrance (palbociclib) and Novartis' Kisqali (ribocicli.

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