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NEW YORK – The US Food and Drug Administration on Wednesday announced the approval of AstraZeneca and Merck's olaparib (Lynparza) for metastatic castration-resistant prostate cancer patients with homologous recombination repair deficiency.

The agency simultaneously also approved two companion diagnostics that may be used to identify best responders to this drug: Myriad Genetics' BRACAnalysis CDx to identify patients with germline BRCA1/2 mutations, and Foundation Medicine's FoundationOne CDx to identify patients with HRR-mutated genes.

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