Difference between revisions of "Abemaciclib (Verzenio)"
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Warner-admin (talk | contribs) m (Text replacement - "[[Category:Drugs FDA" to "[[Category:FDA") |
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=History of changes in FDA indication= | =History of changes in FDA indication= | ||
| − | *9/28/2017: FDA approved in combination with [[Fulvestrant (Faslodex)|fulvestrant]] for women with [[ | + | *9/28/2017: FDA approved in combination with [[Fulvestrant (Faslodex)|fulvestrant]] for women with [[Biomarkers#HR|HR]]-positive, [[Biomarkers#HER2|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 [[ | + | *9/28/2017: FDA approved as monotherapy for women and men with [[Biomarkers#HR|HR]]-positive, [[Biomarkers#HER2|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 [[:Category:Aromatase inhibitors|aromatase inhibitor]] as initial endocrine-based therapy for postmenopausal women with [[ | + | *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)]]-positive, [[Biomarkers#HER2|human epidermal growth factor receptor 2 (HER2)]]-negative advanced or metastatic [[breast cancer]]. |
=Also known as= | =Also known as= | ||
Revision as of 22:35, 8 January 2020
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.
Also known as
- Code name: LY2835219
- Brand name: Verzenio