Difference between revisions of "Talazoparib (Talzenna)"
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*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)'' | *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. | *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. | ||
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| + | ==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== | ||
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[[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