Eli Lilly Submits NDA for Abemaciclib (Verzenio), a CDK4/6 Inhibitor, for HR+/HER2- Breast Cancer in China
Eli Lilly
Global Pharmaceutical R&D and Production Company
Text | Feng Qiu
On November 14, the CDE website showed that Eli Lilly submitted a marketing application for the breast cancer drug abemaciclib.
Verzenio (abemaciclib) was initially approved by the FDA on September 28, 2017, as monotherapy for ER+/HER2- advanced or metastatic breast cancer that has progressed following endocrine therapy and chemotherapy, or in combination with fulvestrant as second-line treatment for HR+/HER2- advanced or metastatic breast cancer that has progressed after endocrine therapy. On February 26, 2018, the FDA approved a third indication for abemaciclib: in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer. Global sales of Verzenio in 2018 amounted to $255 million.
On September 25, 2019, the CDE website indicated that Eli Lilly’s abemaciclib had been approved for clinical trials in China. The indication was for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, to be used in combination with an aromatase inhibitor or fulvestrant as initial endocrine therapy, or for the treatment of women who had previously received endocrine therapy.
Verzenio is the third CDK4/6 inhibitor approved by the FDA. It is an oral solid dosage form. In the field of metastatic breast cancer treatment, abemaciclib is currently the only CDK4/6 inhibitor that can be used either as monotherapy or in combination therapy. CDK4/6 are key regulators of the cell cycle, triggering the transition from the growth phase (G1 phase) to the DNA synthesis phase (S phase). By arresting the cell cycle at the G1 phase, they inhibit the proliferation of tumor cells.
Currently, the CDK4/6 inhibitors for which clinical trial applications have been submitted in China include numerous products, such as Hengrui’s SHR6390, Xuanzhu Pharmaceutical’s Pyroxetin, Yifang Biopharma’s D-0316, Beta Pharma’s BPI-16350, and Chia Tai Tianqing’s TQB3616, indicating that many well-known enterprises are actively developing CDK4/6 inhibitors.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.
