The FDA on October 16, 2018 approved TALZENNA®, a poly (ADP-ribose) polymerase (PARP) 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 TALZENNA®. TALZENNA® is a product of Pfizer Inc.