MedPath

Talazoparib

Generic Name
Talazoparib
Brand Names
Talzenna
Drug Type
Small Molecule
Chemical Formula
C19H14F2N6O
CAS Number
1207456-01-6
Unique Ingredient Identifier
9QHX048FRV

Overview

Talazoparib is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerases (PARPs), enzymes responsible for regulating essential cellular functions, such as DNA transcription and DNA repair. Developed by Pfizer, talazoparib was first approved by the FDA in October 2018 and by the EMA in June 2019. It was approved by Health Canada in September 2020. Talazoparib is currently used in the treatment of BRCA-mutated breast cancer and HRR-mutated prostate cancer.

Background

Talazoparib is an inhibitor of mammalian polyadenosine 5’-diphosphoribose polymerases (PARPs), enzymes responsible for regulating essential cellular functions, such as DNA transcription and DNA repair. Developed by Pfizer, talazoparib was first approved by the FDA in October 2018 and by the EMA in June 2019. It was approved by Health Canada in September 2020. Talazoparib is currently used in the treatment of BRCA-mutated breast cancer and HRR-mutated prostate cancer.

Indication

Talazoparib is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. This indication is approved by the FDA, EMA, and Health Canada. In the US, talazoparib is also indicated in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

Associated Conditions

  • HRR gene-mutated (HRRm) metastatic castration-resistant prostate cancer (mCRPC)
  • Metastatic Breast Cancer
  • Locally Advanced Breast Cancer (LABC)

FDA Approved Products

Talzenna
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2023/06/26
NDC:0069-1501
Talzenna
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:0.1 mg in 1 1
Approved: 2023/06/26
NDC:0069-1031
Talzenna
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:0.75 mg in 1 1
Approved: 2023/06/26
NDC:0069-1751
Talzenna
Manufacturer:U.S. Pharmaceuticals
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/06/26
NDC:63539-295
Talzenna
Manufacturer:Pfizer Laboratories Div Pfizer Inc
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/06/26
NDC:0069-1195

Singapore Approved Products

TALZENNA CAPSULE 0.25MG
Manufacturer:Excella GmbH & Co. KG
Form:CAPSULE
Strength:0.25 mg
Online:Yes
Approved: 2020/05/22
Approval:SIN15944P
TALZENNA CAPSULE 1MG
Manufacturer:Excella GmbH & Co. KG
Form:CAPSULE
Strength:1 mg
Online:Yes
Approved: 2020/05/22
Approval:SIN15945P
TALZENNA CAPSULE 0.1MG
Manufacturer:Excella GmbH & Co. KG
Form:CAPSULE
Strength:0.1 mg
Online:Yes
Approved: 2025/05/21
Approval:SIN17238P
TALZENNA CAPSULE 0.35MG
Manufacturer:Excella GmbH & Co. KG
Form:CAPSULE
Strength:0.35 mg
Online:Yes
Approved: 2025/05/21
Approval:SIN17239P
TALZENNA CAPSULE 0.5MG
Manufacturer:Excella GmbH & Co. KG
Form:CAPSULE
Strength:0.5 mg
Online:Yes
Approved: 2025/05/21
Approval:SIN17240P

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