Difference between revisions of "Talazoparib (Talzenna)"
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==Mechanism of action== | ==Mechanism of action== | ||
PARP inhibitor | PARP inhibitor | ||
+ | |||
+ | *[https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=8313 IUPHAR/BPS] | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Breast_cancer,_BRCA-mutated|BRCA-mutated breast cancer]] | *[[Breast_cancer,_BRCA-mutated|BRCA-mutated breast cancer]] | ||
+ | *[[Prostate cancer]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
− | *10 | + | *2018-10-16: 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)'' |
+ | *2023-06-20: Approved with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant [[prostate cancer]] (mCRPC). ''(Based on TALAPRO-2)'' | ||
+ | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
− | * | + | *2019-06-20: 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. ''(Based on EMBRACA)'' |
− | + | *2023-11-09: CHMP recommends new marketing authorisation - Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant [[prostate cancer]] (mCRPC) in whom chemotherapy is not clinically indicated. | |
+ | |||
+ | ==History of changes in PMDA indication== | ||
+ | *2024-01-18: Newly indicated for the treatment of BRCA mutation-positive, metastatic castration-resistant [[prostate cancer]]. | ||
+ | *2024-01-18: Newly indicated for the treatment of unresectable or recurrent BRCA mutation-positive and HER2-negative [[breast cancer]] in patients who have previously been treated with chemotherapy. | ||
+ | |||
==Also known as== | ==Also known as== | ||
*'''Code name:''' BMN-673 | *'''Code name:''' BMN-673 | ||
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[[Category:Mutation-specific medications]] | [[Category:Mutation-specific medications]] | ||
− | [[Category: | + | [[Category:PARP1 inhibitors]] |
+ | [[Category:PARP2 inhibitors]] | ||
[[Category:Breast cancer medications]] | [[Category:Breast cancer medications]] | ||
+ | [[Category:Prostate cancer medications]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
[[Category:EMA approved in 2019]] | [[Category:EMA approved in 2019]] | ||
+ | [[Category:PMDA approved in 2024]] | ||
[[Category:Pfizer product]] | [[Category:Pfizer product]] |
Latest revision as of 04:09, 1 June 2024
Mechanism of action
PARP inhibitor
Diseases for which it is used
History of changes in FDA indication
- 2018-10-16: Initial approval for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. (Based on EMBRACA)
- 2023-06-20: Approved with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). (Based on TALAPRO-2)
History of changes in EMA indication
- 2019-06-20: 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. (Based on EMBRACA)
- 2023-11-09: CHMP recommends new marketing authorisation - Talzenna is indicated in combination with enzalutamide for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.
History of changes in PMDA indication
- 2024-01-18: Newly indicated for the treatment of BRCA mutation-positive, metastatic castration-resistant prostate cancer.
- 2024-01-18: Newly indicated for the treatment of unresectable or recurrent BRCA mutation-positive and HER2-negative breast cancer in patients who have previously been treated with chemotherapy.
Also known as
- Code name: BMN-673
- Brand name: Talzenna