Difference between revisions of "Tucatinib (Tukysa)"
Jump to navigation
Jump to search
m (→Also known as) |
m |
||
| Line 7: | Line 7: | ||
==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)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2/11/2021: Initial marketing authorization as Tukysa. | ||
==Also known as== | ==Also known as== | ||
| Line 21: | Line 24: | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
| + | [[Category:EMA approved in 2021]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
Revision as of 03:23, 5 December 2021
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 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)
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