FDA expands approval of Myriad Genetics' BRACAnalysis CDx for use with PARP inhibitor Lynparza in breast cancer

Myriad Genetics announced Friday that its BRACAnalysis CDx received expanded FDA approval to include use as a companion diagnostic to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with AstraZeneca and Merck & Co.'s PARP inhibitor Lynparza (olaparib). "BRACAnalysis CDx is the first and only FDA-approved test for use in this indication," Myriad noted.

Johnathan Lancaster, chief medical officer at Myriad, remarked that "as shown in the OlympiAD study, [the] BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza." He suggested that of the 155 000 patients with metastatic breast cancer in the US, an estimated 125 000 do not know their BRCA status, adding that the broader label "significantly expands the population who can access BRCA testing and potentially benefit from PARP inhibition therapy."

In 2014, BRACAnalysis CDx received FDA approval to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with Lynparza. The test later gained the CE mark in the EU, where it is marketed as Tumor BRACAnalysis CDx, with Gary King, Myriad's head of international operations, noting at the time that the decision "allows us to offer a validated tumour-based test for use as a companion diagnostic with Lynparza and future PARP inhibitors in Europe."

More recently, Myriad announced that data from the EMBRACA trial showed that BRACAnalysis CDx successfully identified patients with metastatic breast cancer who responded to Pfizer's experimental PARP inhibitor talazoparib.  

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