FDA Approves Talzenna for gBRCAm HER2– Breast Cancer

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 locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin [Halaven, Eisai], gemcitabine or vinorelbine).

All enrolled patients had a known deleterious or suspected deleterious gBRCA mutation and had received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. 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 primary efficacy outcome was progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review. Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively (hazard ratio, 0.54; 95% CI, 0.41-0.71; P<0.0001).

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression and embryo-fetal toxicity. Most common adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea and decreased appetite. For the product insert, click here.

The FDA also approved the BRACAnalysis CDx test (Myriad Genetics) to identify patients with breast cancer with deleterious or suspected deleterious gBRCA mutation 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.

OCTOBER 18, 2018


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