Lilly's Abemaciclib Receives NMPA Approval for Expanded Indication in High-Risk Early Breast Cancer in China

On September 1, Eli Lilly and Company announced that abemaciclib tablets had been approved by the National Medical Products Administration (NMPA) for an expanded indication, in combination with endocrine therapy (tamoxifen or aromatase inhibitors), as adjuvant treatment for adult patients with early breast cancer who are hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, lymph node-positive, and at high risk of recurrence.

Abemaciclib Tablets were approved for the indication of early breast cancer in December 2021, becoming the first and only CDK4/6 inhibitor in China approved for use in high-risk early-stage patients. This expanded indication marks a further broadening of the population eligible for abemaciclib tablets combined with endocrine therapy, benefiting more HR+, HER2- high-risk early breast cancer patients.

This extended indication approval is mainly based on the 4-year data from the global multicenter Phase III monarchE study. The study enrolled a total of 5,637 patients, including 501 patients from China. The latest results show that postoperative adjuvant endocrine therapy combined with abemaciclib tablets for 2 years in high-risk early breast cancer patients demonstrates clinically meaningful and significant improvements as well as sustained benefits in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) compared to endocrine therapy alone. The safety profile observed in Chinese patients with early breast cancer is consistent with the global population, and the safety spectrum aligns with what has been observed in clinical studies of Chinese patients with advanced breast cancer.

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