CHMP recommends approval of Verzenios in metastatic breast cancer.- Eli Lilly.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Verzenios (abemaciclib), from Eli Lilly, intended for the treatment of locally advanced or metastatic breast cancer. Verzenios will be available as film -coated tablets (50 mg, 100 mg and 150 mg).

The active substance of Verzenios is abemaciclib, a protein kinases inhibitor (ATC code: L01XE50 ) that potently and selectively inhibits cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), leading to suppression of tumour growth. The benefit with Verzenios is its ability to significantly improve progression -free survival in combination with an aromatase inhibitor or fulvestrant.

The most common side effects are diarrhoea, infections, neutropenia, anaemia, fatigue, nausea, vomiting and decreased appetite. The full indication is: "Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine -based therapy, or in women who have received prior endocrine therapy. In pre - or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone -releasing hormone (LHRH) agonist."