Talzenna Approved for Germline BRCA-Mutated, HER2-Negative Breast Cancer

The Food and Drug Administration (FDA) has approved Talzenna (talazoparib; Pfizer) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Concurrently, the FDA has approved Myriad Genetic Laboratories’ BRACAnalysis CDx test as a diagnostic companion to identify patients with breast cancer who are eligible for treatment with Talzenna. 

Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was evaluated in EMBRACA, an open-label trial that randomized patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer (N=431) to receive talazoparib 1mg or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). Patients received no more than 3 prior cytotoxic chemotherapy regimens for their metastatic or locally advanced disease. In addition, patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting.

The major efficacy outcome measure was progression-free survival (PFS) evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, as assessed by blinded independent central review. The estimated median PFS was 8.6 months in the talazoparib arm vs.5.6 months in the chemotherapy arm (hazard ratio [HR] 0.54, 95% CI, 0.41, 0.71; P <.0001). Fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite were the most common adverse reactions associated with therapy. 

Talzenna will be supplied in 0.25mg and 1mg strength capsules in 30-count bottles.

For more information visit Pfizer.com.