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Drugs

, Volume 78, Issue 18, pp 1939–1946 | Cite as

Talazoparib: First Global Approval

  • Sheridan M. Hoy
AdisInsight Report
  • 71 Downloads

Abstract

Talazoparib (TALZENNA™) is an oral inhibitor of the polyadenosine 5′-diphosphoribose polymerase (PARP) enzymes, which play a critical role in repairing DNA single-strand breaks. It has been developed by Pfizer and was recently approved in the USA for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (as detected by a US FDA-approved assay). A regulatory assessment for talazoparib in this patient population is underway in the EU, with talazoparib also undergoing development for use in metastatic castration-resistant prostate cancer and various solid tumours, and as neoadjuvant therapy in early triple negative breast cancer. This article summarizes the milestones in the development of talazoparib leading to its first approval for the treatment of adults with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative, locally advanced or metastatic breast cancer.

Notes

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Sheridan Hoy is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

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