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FDA Approves Talazoparib for BRCA-Mutated, HER2-Negative Breast Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Oct 16, 2018

The FDA has approved talazoparib (Talzenna) for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer, according to Pfizer, the manufacturer of the PARP inhibitor.

 
To be eligible for enrollment, patients were required to have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Moreover, patients must have received treatment with an anthracycline and/or a taxane, unless contraindicated, in the neoadjuvant, adjuvant, and/or metastatic setting. The primary endpoint was progression-free survival (PFS), as assessed by blinded independent central review. Secondary endpoints were overall survival (OS), safety, and overall response rate (ORR).

Results demonstrated that, at a median follow-up of 11.2 months, the median PFS was 8.6 months (95% CI, 7.2-9.3) in the talazoparib arm and 5.6 months (95% CI, 4.2-6.7) in the chemotherapy arms, respectively (HR, 0.54; 95% CI: 0.41-0.71; P <.0001). The ORR was 62.6% (95% CI, 55.8-69.0) versus 27.2% (95% CI, 19.3-36.3), respectively (odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001). The PFS benefit with talazoparib was observed across all predetermined patient subgroups.

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