Lilly receives approval for expanded indication for breast cancer therapy

pharmafile | March 6, 2023 | News story | Research and Development  

Following positive data from Eli Lilly’s phase 3 monarchE trial, the FDA has granted approval for the expanded indication for Verzenio (abemaciclib) to treat patients with breast cancer.

Verzenio is approved alongside endocrine therapy (ET) as an adjuvant treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) in adult patients who are at a high risk of recurrence.

Patients can now be identified based on tumour size, nodal status and tumour grade to receive the treatment.

This approval follows positive data obtained in the randomised, open-label, two cohort, multicentre, global phase 3 monarchE trial, which included 5,637 patients with HR+, HER2-, node-positive EBC with a high risk of recurrence. The trial showed that the drug alongside ET had a 35% reduction in recurrence risk compared to ET alone.

Jacob Van Naarden, chief executive officer at Loxo Oncology (Loxo@Lilly), commented: “This expanded approval will allow us to bring Verzenio to many more women and men with HR+, HER-2-, high risk early breast cancer in the curative setting – before patients experience recurrence, potentially to incurable metastatic disease. […] The initial adjuvant approval for Verzenio changed the treatment paradigm, and the strength of the monarchE results supporting this approval underscores the role this differentiated CDK4/6 inhibitor can play in reducing the risk of recurrence in early breast cancer.”


Betsy Goodfellow

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