FDA Grants Priority Review to Lynparza as Treatment for Mutated Metastatic Castration-resistant Prostate Cancer

FDA Grants Priority Review to Lynparza as Treatment for Mutated Metastatic Castration-resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) has granted priority review status to an application to extend the use of the oral therapy Lynparza (olaparib) to men with metastatic castration-resistant prostate cancer (mCRPC) who carry mutations in DNA repair genes, including BRCA or ATM, and who have failed prior treatment with a new hormone therapy. Priority review status cuts the time to six months for the FDA to make its decision, from the typical 10 months under standard review. A final resolution on the supplemental new drug application is expected for the second quarter of this year, according to a press release. The application from AstraZeneca and Merck (known as EMD Serono outside the U.S. and Canada) was based on positive results from the
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