MedPath

Talazoparib

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

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

Phase 2
Terminated
Conditions
Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Interventions
First Posted Date
2014-01-14
Last Posted Date
2019-10-14
Lead Sponsor
Pfizer
Target Recruit Count
84
Registration Number
NCT02034916
Locations
🇺🇸

Marin Cancer Care, Inc., Greenbrae, California, United States

🇺🇸

UCLA Hematology-Oncology, Santa Monica, California, United States

🇺🇸

Stanford Cancer Institute, Stanford, California, United States

and more 67 locations

A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

Phase 3
Completed
Conditions
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Breast Neoplasms
Interventions
Drug: Physician's-Choice
Drug: talazoparib
First Posted Date
2013-09-19
Last Posted Date
2022-01-20
Lead Sponsor
Pfizer
Target Recruit Count
431
Registration Number
NCT01945775
Locations
🇺🇸

University of California Los Angeles, Los Angeles, California, United States

🇺🇸

Los Angeles Hematology Oncology Medical Group, Los Angeles, California, United States

🇺🇸

University of Maryland, Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 267 locations

Study of Talazoparib, a PARP Inhibitor, in Patients With Advanced or Recurrent Solid Tumors

Phase 1
Completed
Conditions
Advanced or Recurrent Solid Tumors
Breast Neoplasms
Ovarian Cancer, Epithelial
Ewing Sarcoma
Small Cell Lung Carcinoma
Prostate Cancer
Pancreas Cancer
Interventions
First Posted Date
2011-02-01
Last Posted Date
2019-01-10
Lead Sponsor
Pfizer
Target Recruit Count
113
Registration Number
NCT01286987
Locations
🇺🇸

Ronald Reagan UCLA Medical Center, Los Angeles, California, United States

🇺🇸

UCLA Hematology/Oncology, Los Angeles, California, United States

🇺🇸

Santa Monica - UCLA Medical Center & Orthopaedic Hospital, Santa Monica, California, United States

and more 12 locations
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