FDA approves BRACAnalysis CDx as companion diagnostic for Talzenna in HER2- breast cancer.- Myriad Genetics.
Myriad Genetics announced that the FDA has approved BRACAnalysis CDx to be used by healthcare professionals to identify patients with HER2-negative metastatic breast cancer (mBC) who have a germline BRCA mutation and are eligible for treatment with Pfizer�s PARP (poly ADP ribose polymerase) inhibitor, Talzenna (talazoparib). The FDA approvals are based on results from the EMBRACA trial that evaluated Talzenna versus physician�s choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or mBC.
Comment: Myriad�s BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from Talzenna.
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