Difference between revisions of "Abemaciclib (Verzenio)"
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*9/28/2017: FDA approved as monotherapy for women and men with [[Biomarkers#HR|HR]]-[[Biomarkers#Normal_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. | *9/28/2017: FDA approved as monotherapy for women and men with [[Biomarkers#HR|HR]]-[[Biomarkers#Normal_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. | ||
*2/26/2018: 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#Normal_expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]]. | *2/26/2018: 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#Normal_expression|positive]], [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-[[Biomarkers#Normal_expression|negative]] advanced or metastatic [[breast cancer]]. | ||
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| + | == Manufacturer Package Insert== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf Abemaciclib (Verzenio) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf Abemaciclib (Verzenio) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
Revision as of 22:51, 8 March 2021
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
- 9/28/2017: FDA approved in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
- 9/28/2017: 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.
- 2/26/2018: 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.
Manufacturer Package Insert
Also known as
- Code name: LY2835219
- Brand names: Verzenio, Verzenios