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Verzenio ® (abemaciclib) tablets
50mg, 100mg, 150mg, 200mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
How has the U.S. label expansion of Verzenio® (abemaciclib) approved on March 3, 2023 impacted patients receiving early breast cancer treatment?
This FDA approval broadens the indicated use of abemaciclib, in combination with endocrine therapy (ET), for the treatment of people with HR+, HER2-, node-positive, EBC at a high risk of recurrence, and removes Ki-67 as a patient selection factor.
How has the U.S. label expansion of Verzenio® (abemaciclib) approved on March 3, 2023 impacted patients receiving early breast cancer treatment?
On March 3, 2023, the Food and Drug Administration (FDA) updated previously approved early breast cancer (EBC) indications for abemaciclib as follows
- in combination with endocrine therapy (ET) (tamoxifen or an aromatase inhibitor [AI]) for the adjuvant treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive EBC at high risk of recurrence.1
With this label expansion, high risk patients eligible for abemaciclib can now be identified solely based on
- nodal status
- tumor size, and
- tumor grade2
Patients are eligible with 4+ positive nodes, or 1-3 positive nodes and at least one of the following: tumors that are ≥5 cm or Grade 3.2
This expanded adjuvant indication removes the requirement that patients who meet the criteria described above also have a high KI-67 score.2
Relative to the previous FDA approval of abemaciclib in EBC, it is estimated that this new indication roughly doubles the population eligible for abemaciclib based on clinicopathologic features.2
Enclosed Prescribing Information
References
1Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: March 22, 2023