Difference between revisions of "Tucatinib (Tukysa)"
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*[[Colorectal cancer, HER2-positive|HER2+ colorectal cancer]] | *[[Colorectal cancer, HER2-positive|HER2+ colorectal cancer]] | ||
==History of changes in FDA indication== | ==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 EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2021-02-11: Initial marketing authorization as Tukysa. |
==Also known as== | ==Also known as== | ||
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