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Talazoparib Approved for BRCA-Mutated, HER2-Negative Breast Cancer


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On October 16, 2018, the U.S. Food and Drug Administration approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib (the BRACAnalysis CDx test). Approval of both talazoparib and the companion diagnostic was based on the open label, phase III EMBRACE trial. 

The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryofetal toxicity. The recommended talazoparib dose is 1 mg taken as a single oral daily dose, with or without food.

For more information, visit FDA.gov. ■


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