Difference between revisions of "Talazoparib (Talzenna)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*10/16/2018: Initial approval for patients with deleterious or suspected deleterious [[Biomarkers#Germline|germline]] [[Biomarkers#BRCA|BRCA]]-[[Biomarkers#Alterations|mutated]] (gBRCAm), [[Biomarkers#ERBB2|HER2]]-[[Biomarkers#negative|negative]] locally advanced or metastatic [[breast cancer]]. ''(Based on EMBRACA)'' | *10/16/2018: Initial approval for patients with deleterious or suspected deleterious [[Biomarkers#Germline|germline]] [[Biomarkers#BRCA|BRCA]]-[[Biomarkers#Alterations|mutated]] (gBRCAm), [[Biomarkers#ERBB2|HER2]]-[[Biomarkers#negative|negative]] locally advanced or metastatic [[breast cancer]]. ''(Based on EMBRACA)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *6/20/2019: Initial authorization as Talzenna | ||
| + | *Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BMN-673 | *'''Code name:''' BMN-673 | ||
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[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2019]] | ||
[[Category:Pfizer product]] | [[Category:Pfizer product]] | ||
Revision as of 22:31, 2 January 2023
Mechanism of action
PARP inhibitor
Diseases for which it is used
History of changes in FDA indication
- 10/16/2018: Initial approval for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. (Based on EMBRACA)
History of changes in EMA indication
- 6/20/2019: Initial authorization as Talzenna
- Talzenna is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2 mutations, who have HER2-negative locally advanced or metastatic breast cancer. Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.
Also known as
- Code name: BMN-673
- Brand name: Talzenna