FDA Approves Talzenna for gBRCAm HER2-Negative Breast Cancer

By SPC News Staff

The FDA approved talazoparib (Talzenna, Pfizer), a poly(adenosine diphosphate–ribose) polymerase inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2 negative locally advanced or metastatic breast cancer. 

Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.

Approval was based on EMBRACA, an open label trial randomly assigning 431 patients (2:1) with gBRCAm HER2 negative