Lilly's CDK4/6 Inhibitor Abemaciclib Approved in China for Adjuvant Treatment of Early Breast Cancer

By Medicine Viewpoint

On January 6, Eli Lilly and Company announced that its new anti-tumor drug, abemaciclib tablets (brand name: Verzenio), received approval from the National Medical Products Administration (NMPA) of China for use in combination with endocrine therapies such as tamoxifen or aromatase inhibitors. It is indicated for adjuvant treatment of adult patients with HR-positive, HER2-negative, lymph node-positive, high-risk of recurrence, and Ki-67 ≥20% early breast cancer. According to the press release, abemaciclib has become the first and only CDK4/6 inhibitor approved in mainland China for the treatment of early breast cancer patients.

Breast cancer is the most common cancer among women globally. It is estimated that 90% of breast cancers are diagnosed at an early stage. The most common subtype is hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, which accounts for approximately 70% of all breast cancer patients. About 30% of patients diagnosed with HR-positive, HER2-negative early breast cancer still face the risk of cancer recurrence. These patients need new treatment options.

Abemaciclib Tablets are inhibitors of cyclin-dependent kinases (CDK) 4 and 6, activated by binding to cyclin D. They can inhibit the phosphorylation of Rb and block cells from progressing from the G1 phase to the S phase of the cell cycle, leading to cellular senescence and apoptosis. This approval marks another new indication for Abemaciclib Tablets after they were approved by the NMPA in December 2020 for the treatment of HR-positive, HER2-negative locally advanced or metastatic breast cancer.

According to the press release, the approval of this new indication was based on the results of a randomized, multicenter, Phase 3 clinical study named monarchE. The data showed that in adult patients with HR-positive, HER2-negative, lymph node-positive, high-risk of recurrence, and Ki-67≥20% early breast cancer, compared with standard endocrine therapy, the combination of abemaciclib and standard endocrine therapy significantly reduced the risk of recurrence by 37% in high-risk early breast cancer patients, with an absolute benefit of 7.1% in the 3-year invasive disease-free survival (IDFS) rate; at the same time, the combination of abemaciclib and standard endocrine therapy also significantly reduced the risk of distant metastasis by 40%, with an absolute benefit of 5.2% in the 3-year distant relapse-free survival (DRFS) rate. The safety profile of the Chinese subgroup in the monarchE study was consistent with the overall population and also consistent with the known safety profile of abemaciclib in treating Chinese patients with advanced breast cancer.

References:

[1] Eli Lilly's New Breast Cancer Drug Verzenio^®(Abemaciclib Tablets) Receives New Indication for Early Breast Cancer, Ushering in a New Era of Adjuvant Treatment for High-Risk HR+, HER2- Early Breast Cancer Patients. Retrieved Jan 6, 2022, from https://mp.weixin.qq.com/s/HtMOnldKM6-5kbhf5kQi8A

(Original text has been abridged)

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