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First Survival Win for CDK4/6 Inhibitors in High-Risk Early-Breast Cancer

Verzenio reduced death risk by 15.8% and cut metastatic disease by 32% over seven years in high-risk early breast cancer patients, monarchE trial data show.

  • Eli Lilly presented seven-year monarchE results at the ESMO cancer congress and in Annals of Oncology showing two years of Verzenio improved overall survival to 86.8% versus 85% with endocrine therapy alone.
  • The results will form the basis for regulatory filings to seek a label extension, as Eli Lilly aims to keep Verzenio ahead of Novartis's Kisqali, which won FDA approval last year based on the NATALEE trial.
  • MonarchE results reveal specific risk reductions including 15.8% lower death risk and 32% less metastasis at seven years with 6.4% on Verzenio versus 9.4% on endocrine therapy.
  • Commercially, the drug's sales picture shows $3 billion in 2024 sales and a 60% rise to $2.1 billion in H1 2025, with Verzenio’s 2021 approval driving more than $5 billion a year.
  • Investigators and rapporteurs framed the findings cautiously, noting OS `continues to show an encouraging trend,' and Stephen Johnston emphasized `For patients, survival is what matters most,' while Angela DeMichele called for longer follow-up.
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These days, the European Congress of Oncology will present the promising results of the abemaciclib trial in patients at high risk of breast cancer recurrence.

·Madrid, Spain
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PR Newswire broke the news in United States on Friday, October 17, 2025.
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