FDA Approves Olaparib for Ovarian Cancer

(December 19, 2014) The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Olaparib (Lynparza) for advanced, BRCA-mutated ovarian cancer, the first approval of a drug in the PARP (poly ADP-ribose polymerase) inhibitor class.

The FDA also approved Myriad Genetics’ BRACAnalysis CDx test to determine patients’ BRCA status as a companion diagnostic for determining whether an individual patient is a candidate for Olaparib. This is the FDA’s first approval of an LDT [lab-developed test] companion diagnostic.

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