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FDA classifies Olaparib as a Breakthrough Therapy

Paul Edwards

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The United States Food and Drug Administration (FDA) has classified Olaparib (brand name Lynparza) as a Breakthrough Therapy for men with metastatic castrate-resistant prostate cancer with DNA repair defects in their tumours.


This means the application to have Olaparib approved by the FDA for prostate cancer will be fast tracked and it is likely that Olaparib will be approved later this year.



The FDA's decision to recognise Olaparib as a Breakthrough Therapy was reported in ONCLive

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