CHMP recommends change of indication of Verzenios in breast cancer.- Eli Lilly
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Verzenios (abemaciclib)(Verzenio in the US), from Eli Lilly. The CHMP adopted an extension to the existing indication to include use in early breast cancer at high risk of recurrence.
The full indication now reads: Verzenios in combination with endocrine therapy is now indicated for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence. In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a LHRH agonist.
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