TriangleLABELS · e189da1b-d503-48a4-aba3-4f93a3fab2d3
Talzenna
Open original source → · Download preserved record
Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2025-12-18
- Captured
- 2026-09-09T23:38:02.384588+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
Full extracted label fields
- application numbers
- NDA211651
- boxed warning exact
- brand names
- Talzenna
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f2423edd-6d24-495c-aec1-c2f457f08d9a
- generic names
- TALAZOPARIB
- id
- e189da1b-d503-48a4-aba3-4f93a3fab2d3
- indications and usage exact
- 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). ( 1.2 ) 1.1 BRCA -mutated (g BRCA m) HER2-negative Locally Advanced or Metastatic Breast Cancer TALZENNA is indicated as a single agent for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene ( BRCA )-mutated (g BRCA m) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA [see Dosage and Administration (2.1) ] . 1.2 HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) TALZENNA is indicated in combination with enzalutamide for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) [see Dosage and Administration (2.3) ] .
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Pfizer Laboratories Div Pfizer Inc
- matched search terms
- cancer
- package ndcs
- 0069-0296-30
- 0069-1195-30
- 0069-1501-30
- 0069-1751-30
- 0069-1031-30
- 0069-1235-30
- product ndcs
- 0069-0296
- 0069-1195
- 0069-1501
- 0069-1751
- 0069-1031
- 0069-1235
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 2099946
- 2099952
- 2099954
- 2099956
- 2591510
- 2591512
- 2591520
- 2591521
- 2639960
- 2639962
- 2639964
- 2639966
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00700.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 700
- total
- 830
- sha256
- 24c521d95bd19e54a354ae592997052a3a1b19254da1496b3a98a5e9bac4ed08
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22e189da1b-d503-48a4-aba3-4f93a3fab2d3%22
- spl effective date
- 2025-12-18
- spl effective time
- 20251218
- spl set id
- f2423edd-6d24-495c-aec1-c2f457f08d9a
- spl version
- 19
- substance names
- TALAZOPARIB TOSYLATE
- uniis
- 02WK9U5NZC
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
Drugs@FDA application source records
- application number
- NDA211651
- payload
- all indexed label documents
- Appl No
- 211651
- Application Docs Date
- 2018-10-16 00:00:00
- Application Docs ID
- 55956
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211651s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 211651
- Application Docs Date
- 2019-09-25 00:00:00
- Application Docs ID
- 60096
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211651s002lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2020-03-10 00:00:00
- Application Docs ID
- 62110
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s005lbl.pdf
- Submission No
- 5
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2020-10-27 00:00:00
- Application Docs ID
- 65034
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211651s006lbl.pdf
- Submission No
- 6
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2021-09-10 00:00:00
- Application Docs ID
- 68569
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s007lbl.pdf
- Submission No
- 7
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2021-09-21 00:00:00
- Application Docs ID
- 68670
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211651s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2023-06-20 00:00:00
- Application Docs ID
- 74554
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211651s010lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2024-02-07 00:00:00
- Application Docs ID
- 77417
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211651s012lbl.pdf
- Submission No
- 12
- Submission Type
- SUPPL
- Appl No
- 211651
- Application Docs Date
- 2025-06-13 00:00:00
- Application Docs ID
- 82561
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211651s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- all submission records
- Appl No
- 211651
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 13
- Submission Status
- AP
- Submission Status Date
- 2025-06-12 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 12
- Submission Status
- AP
- Submission Status Date
- 2024-02-06 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 10
- Submission Status
- AP
- Submission Status Date
- 2023-06-20 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 9
- Submission Status
- AP
- Submission Status Date
- 2021-09-21 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 8
- Submission Status
- AP
- Submission Status Date
- 2021-09-20 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 7
- Submission Status
- AP
- Submission Status Date
- 2021-09-09 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 6
- Submission Status
- AP
- Submission Status Date
- 2020-10-22 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 5
- Submission Status
- AP
- Submission Status Date
- 2020-03-09 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 2
- Submission Status
- AP
- Submission Status Date
- 2019-09-24 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 1
- Submission Status
- AP
- Submission Status Date
- 2021-06-16 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 211651
- Review Priority
- PRIORITY
- Submission Class Code ID
- 7
- Submission No
- 1
- Submission Status
- AP
- Submission Status Date
- 2018-10-16 00:00:00
- Submission Type
- ORIG
- Submissions Public Notes
- application number
- NDA211651
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211651
- has approved submission record
- true
- latest approved submission date
- 2025-06-12
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 211651
- Application Docs Date
- 2025-06-13 00:00:00
- Application Docs ID
- 82561
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211651s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- official application record
- Appl No
- 211651
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- PFIZER
- openfda application present
- true
- products
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 0.25MG BASE
- marketing status
- Discontinued
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 002
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 1MG BASE
- marketing status
- Discontinued
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 003
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 0.5MG BASE
- marketing status
- Discontinued
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 004
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 0.75MG BASE
- marketing status
- Discontinued
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 005
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 0.1MG BASE
- marketing status
- Discontinued
- Active Ingredient
- TALAZOPARIB TOSYLATE
- Appl No
- 211651
- Drug Name
- TALZENNA
- Form
- CAPSULE;ORAL
- Product No
- 006
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 0.35MG BASE
- marketing status
- Discontinued
Source passages and status connections
Passage 1 · indication intro context
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- 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select
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- 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer
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- start
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- Source null
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- Source null
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- Source null
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- Source null
- limitations
- Source null
- line
- Source null
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- Source null
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- Source null
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- Source null
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Passage 2 · positive indication candidate
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- 1 INDICATIONS AND USAGE TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) • In combination with enzaluta
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- • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mu
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- As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic b
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Preserved source evidence · Not medical advice