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Talzenna FDA Approval History

FDA Approved: Yes (First approved October 16, 2018)
Brand name: Talzenna
Generic name: talazoparib
Dosage form: Capsules
Company: Pfizer Inc.
Treatment for: Breast Cancer

Talzenna (talazoparib) is an oral poly ADP ribose polymerase (PARP) inhibitor indicated for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.

Development Timeline for Talzenna

Oct 16, 2018Approval  FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
Jun  7, 2018U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
Dec 13, 2017Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer
Jun  3, 2017Pfizer Presents Final Phase 2 Data on Investigational PARP Inhibitor Talazoparib in Patients with Germline BRCA-Positive Advanced Breast Cancer

Further information

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