Myriad Signs Commercialization Plan With Pfizer - Quick Facts

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(RTTNews.com) - Myriad Genetics, Inc. ( MYGN ) announced that it has signed a commercialization plan with Pfizer Inc. under an existing companion diagnostic agreement, in which Myriad is pursuing U.S. FDA approval for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer's investigational PARP inhibitor, talazoparib. The companies will collaborate on certain commercial activities intended to support the use of the BRACAnalysis CDx in identifying patients for potential treatment with talazoparib following FDA approval.

Talazoparib and BRACAnalysis CDx currently are under FDA review, with New Drug Application and Supplementary Premarket Approval submissions based on results from the EMBRACA trial, which evaluated talazoparib versus physician's choice chemotherapy in patients with germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Myriad anticipates a regulatory decision from the FDA by December 2018.

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