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FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants Priority Review

08:00 EDT 18 Oct 2017 | World Pharma News

AstraZenecaAstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings.

Original Article: FDA accepts regulatory submission for Lynparza in metastatic breast cancer and grants Priority Review

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