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Talazoparib Approved in Europe for BRCA-Mutant Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Friday, Jun 21, 2019

Andreas Penk, MD

Andreas Penk, MD

The European Commission has approved single-agent talazoparib (Talzenna) for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.1

The approval is based on findings from the phase III EMBRACA study, in which talazoparib led to a 46% reduction in the risk of disease progression a median compared with standard chemotherapy in patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.2

“Today’s approval of Talzenna for certain patients with advanced-stage breast cancer and an inherited BRCA mutation is the latest example of our successful precision medicine approach to drug development,” Andreas Penk, MD, regional president, Oncology International Developed Markets at Pfizer, the developer of talazoparib, stated in a press release. “This important milestone builds on Pfizer’s decades-long legacy of developing therapies that improve outcomes for patients with breast cancer. We are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily, alternative treatment to chemotherapy.”

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