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Expanded Indications

The US Food and Drug Administration has expanded the indications for both AstraZeneca's PARP inhibitor Lynparza and Myriad Genetics' BRACAnalysis CDx test, as GenomeWeb reported Friday.

AstraZeneca's Lynparza (olaparib) is now approved to treat metastatic breast cancer in patients with inherited BRCA mutations. According to the FDA, it is the first PARP inhibitor to be approved to treat breast cancer as well as the first drug approved specifically to treat metastatic breast cancer patients with BRCA mutations. The Associated Press notes that Lynparza has been on the market since 2014 as an ovarian cancer drug.

Myriad Genetics' BRACAnalysis CDx test, meanwhile, can identify patients with germline BRCA mutations who may then benefit from treatment with Lynparza. BRACAnalysis CDx was approved in 2014 as a companion diagnostic for Lynparza, according to GenomeWeb.

"While there is currently no cure for metastatic breast cancer, today's approval offers a new, targeted option that may help to delay disease progression for these patients," says Susan Domchek from the University of Pennsylvania's Abramson Cancer Center, who led the trial the expanded approval was based on, in a statement.

The AP notes that Lynparza will cost $13,886 per month without insurance.

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