FDA Approves Talzenna for gBRCAm HER2-negative Advanced Breast Cancer
FDA Approves Talzenna for gBRCAm HER2-negative Locally Advanced or Metastatic Breast Cancer
by Dr. C.H. Weaver M.D. 10/26/2018
The United States Food and Drug Administration (FDA) has approved Talzenzza (talazoparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, for breast cancer 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 Talzenzza.
The approval of Talzenna was based on the EMBRACA clinical trial in which 431 patients with gBRCAm HER2‑negative locally advanced or metastatic breast cancer were treated with either Talzenna or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and could not have received more than 3 prior chemotherapy treatment regimens. The Talzeena treated patients were found to have a modest delay in in progression of cancer of about 3 months.
The FDA also approved the BRACAnalysis CDx test to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.