Eli Lilly’s Verzenio (abemaciclib) Receives the US FDA’s Approval for People with HR+ HER2- High Risk Early Breast Cancer

Shots:

• The US FDA has approved Verzenio + ET for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test
• The approval is based on subgroup analyses of P-III monarchE trial with additional follow-up, conducted post-hoc. In this analysis, Verzenio + ET demonstrated a 37% reduction in the risk of BC recurrence or death vs ET alone for patients with benefits in IDFS event rate of 7.1% @3yrs.
• IDFS events (104 vs 158). Verzenio is the first addition to adjuvant endocrine therapy approved by the FDA in nearly two decades for the treatment of HR+ HER2- EBC

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