Difference between revisions of "Tucatinib (Tukysa)"
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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. | 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== | ==History of changes in FDA indication== | ||
*4/17/2020: 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)'' | *4/17/2020: 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)'' | ||
+ | *1/19/2023: 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 EMA indication== | ==History of changes in EMA indication== | ||
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[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
+ | [[Category:Colorectal cancer medications]] | ||
[[Category:EMA approved in 2021]] | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] |
Revision as of 13:47, 20 January 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
- 4/17/2020: 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)
- 1/19/2023: 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
- 2/11/2021: Initial marketing authorization as Tukysa.
Also known as
- Code name: ARRY-380, ONT-380
- Generic name: irbinitinib
- Brand name: Tukysa