Difference between revisions of "Abemaciclib (Verzenio)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2017-09-28: FDA approved in combination with [[Fulvestrant (Faslodex)|fulvestrant]] for women with [[Biomarkers#HR|HR]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|HER2]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] with disease progression following endocrine therapy. ''(Based on MONARCH 2)'' |
| − | * | + | *2017-09-28: FDA approved as monotherapy for women and men with [[Biomarkers#HR|HR]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|HER2]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]] with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. ''(Based on MONARCH 1)'' |
| − | * | + | *2018-02-26: FDA approved in combination with an [[:Category:Aromatase inhibitors|aromatase inhibitor]] as initial endocrine-based therapy for postmenopausal women with [[Biomarkers#HR|hormone receptor (HR)]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]]. ''(Based on MONARCH 3)'' |
| − | *10 | + | *2021-10-12: Approved with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with [[Biomarkers#HR|hormone receptor (HR)]]-[[Biomarkers#Expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]], node-positive, early [[breast cancer]] at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. ''(Based on monarchE)'' |
| − | * | + | *2023-03-03: Approved with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early [[breast cancer]] at high risk of recurrence. ''(Based on monarchE; Ki-67 biomarker requirement removed)'' |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2018-09-26: Initial authorization as Verzenios |
| + | ==History of changes in Health Canada indication== | ||
| + | *2019-04-05: Initial notice of compliance | ||
== Manufacturer Package Insert== | == Manufacturer Package Insert== | ||
*[https://uspl.lilly.com/verzenio/verzenio.html#pi Abemaciclib (Verzenio) Package Insert]<ref>[https://uspl.lilly.com/verzenio/verzenio.html#pi Abemaciclib (Verzenio) Package Insert]</ref> | *[https://uspl.lilly.com/verzenio/verzenio.html#pi Abemaciclib (Verzenio) Package Insert]<ref>[https://uspl.lilly.com/verzenio/verzenio.html#pi Abemaciclib (Verzenio) Package Insert]</ref> | ||
| Line 33: | Line 35: | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
[[Category:EMA approved in 2018]] | [[Category:EMA approved in 2018]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
Revision as of 17:24, 1 April 2023
Mechanism of action
From NCI Drug Dictionary: An orally available cyclin-dependent kinase (CDK) inhibitor that targets the CDK4 (cyclin D1) and CDK6 (cyclin D3) cell cycle pathway, with potential antineoplastic activity. Abemaciclib specifically inhibits CDK4 and 6, thereby inhibiting retinoblastoma (Rb) protein phosphorylation in early G1.
Diseases for which it is used
History of changes in FDA indication
- 2017-09-28: FDA approved in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. (Based on MONARCH 2)
- 2017-09-28: FDA approved as monotherapy for women and men with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. (Based on MONARCH 1)
- 2018-02-26: FDA approved in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. (Based on MONARCH 3)
- 2021-10-12: Approved with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. (Based on monarchE)
- 2023-03-03: Approved with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. (Based on monarchE; Ki-67 biomarker requirement removed)
History of changes in EMA indication
- 2018-09-26: Initial authorization as Verzenios
History of changes in Health Canada indication
- 2019-04-05: Initial notice of compliance
Manufacturer Package Insert
Also known as
- Code name: LY2835219
- Brand names: Verzenio, Verzenios