Difference between revisions of "Tucatinib (Tukysa)"
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==Mechanism of action== | ==Mechanism of action== | ||
| − | From the [https://www.annalsofoncology.org/article/S0923-7534(19)32228-8 | + | From the [https://www.annalsofoncology.org/article/S0923-7534(19)32228-8 NCI Drug Dictionary]: An orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity. Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells. |
| + | ==Diseases for which it is established== | ||
| + | *[[Breast cancer, HER2-positive|HER2+ breast cancer]] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| − | *[[ | + | *[[Colorectal cancer, HER2-positive|HER2+ colorectal cancer]] |
| + | ==History of changes in FDA indication== | ||
| + | *2020-04-17: Initial approval in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|positive]] [[breast cancer]], including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. ''(Based on HER2CLIMB)'' | ||
| + | *2023-01-19: Granted accelerated approval in combination with trastuzumab for [[Biomarkers#RAS|RAS]] wild-type [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|positive]] unresectable or metastatic [[colorectal cancer]] that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ''(Based on MOUNTAINEER)'' | ||
| − | ==History of changes in | + | ==History of changes in EMA indication== |
| − | * | + | *2021-02-11: Initial marketing authorization as Tukysa. |
==Also known as== | ==Also known as== | ||
| Line 20: | Line 25: | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| + | [[Category:Colorectal cancer medications]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
Latest revision as of 01:45, 5 May 2023
Mechanism of action
From the NCI Drug Dictionary: An orally bioavailable inhibitor of the human epidermal growth factor receptor tyrosine kinase ErbB-2 (also called HER2) with potential antineoplastic activity. Tucatinib selectively binds to and inhibits the phosphorylation of ErbB-2, which may prevent the activation of ErbB-2 signal transduction pathways, resulting in growth inhibition and death of ErbB-2-expressing tumor cells.
Diseases for which it is established
Diseases for which it is used
History of changes in FDA indication
- 2020-04-17: Initial approval in combination with trastuzumab and capecitabine, for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. (Based on HER2CLIMB)
- 2023-01-19: Granted accelerated approval in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. (Based on MOUNTAINEER)
History of changes in EMA indication
- 2021-02-11: Initial marketing authorization as Tukysa.
Also known as
- Code name: ARRY-380, ONT-380
- Generic name: irbinitinib
- Brand name: Tukysa