Eli Lilly granted label extension for Verzenio in the USA

27 February 2018

Eli Lilly (NYSE: LLY) has been granted US FDA approval for Verzenio (abemaciclib) in a new indication, expanding the marketable treatments for the therapy to include initial endocrine-based therapy for certain metastatic breast cancer patients, in combination with an aromatase inhibitor (AI).

In September last year the therapy became the first and only cyclin-dependent kinase (CDK)4 & 6 inhibitor approved in combination with AstraZeneca’s (LSE: AZN) Faslodex (fulvestrant), and as a single agent, in metastatic breast cancer.

This approval of Verzenio as initial therapy in combination with an AI is based on the efficacy and safety demonstrated in the pivotal MONARCH 3 clinical trial.

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