Study: Myriad Genetics' BRACAnalysis CDx test identifies breast cancer patients who respond to Pfizer's talazoparib

Myriad Genetics announced Tuesday that study data presented at the San Antonio Breast Cancer Symposium (SABCS) showed that the BRACAnalysis CDx test successfully identified patients with metastatic breast cancer (MBC) who responded to Pfizer's investigational PARP inhibitor talazoparib. Mark C. Capone, Myriad Genetics CEO, said that "BRACAnalysis CDx is the only germline companion diagnostic test approved by the FDA to identify patients with BRCA1/2 mutations."

The EMBRACA trial included around 400 patients with germline BRCA mutations as determined by the BRACAnalysis CDx test. Results suggested that patients with locally advanced and/or MBC demonstrated superior progression-free survival (PFS) when treated with talazoparib versus physician's choice standard-of-care chemotherapy. "The PFS benefit was consistent across metastatic BRCA-positive patients, including those with hormone receptor-positive and triple negative disease," Myriad Genetics added.

In 2013, Myriad initially announced its collaboration to develop a novel companion diagnostic test for talazoparib. Under the deal, which was originally with BioMarin Pharmaceutical, now part of Pfizer, Myriad Genetics plans to submit a supplementary premarket approval (sPMA) application to the FDA under its existing PMA for BRACAnalysis CDx to include talazoparib.

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