Talzenna Approved for HER2-Negative, Locally Advanced Breast Cancer with Germline BRCA Mutations

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First


On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-­negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as identified by an FDA-approved test.

On the same day, the FDA approved the companion diagnostic BRACAnalysis CDx test, to identify patients with breast cancer who are candidates for talazoparib therapy, namely, those with deleterious or suspected deleterious germ­line BRCA mutation.

This approval was based on results of a phase 3, international, open-label clinical trial of 431 patients with germline BRCA-positive, HER2-negative, locally advanced or metastatic breast cancer. Enrolled patients had received ≤3 cytotoxic chemotherapy regimens and were randomized to talazoparib therapy or to physician’s choice of chemotherapy.

The primary end point was progression-free survival (PFS). At a median follow-up of 11.2 months, the median PFS was 8.6 months in the talazoparib arm versus 5.6 months in the chemotherapy arm (hazard ratio, 0.54; 95% confidence interval, 0.41-0.71; P <.0001).

The most common (≥20%) adverse events of any grade with talazoparib were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and reduced appetite.