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Talazoparib Approaches EU Approval for BRCA-Mutated, HER2-Negative Breast Cancer

OncLive Staff
Published: Monday, Apr 29, 2019

Chris Boshoff, MD, PhD

Chris Boshoff, MD, PhD
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of talazoparib (Talzenna) for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2 mutations, according to Pfizer, the manufacturer of the PARP inhibitor.

If approved, the indication would stipulate that eligible patients must have prior treatment with an anthracycline and/or a taxane in the neoadjuvant/adjuvant locally advanced or metastatic setting. Further, eligible patients with HR-positive disease must first have received endocrine-based therapy. The European Commission will now be reviewing the application for a final approval decision.

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