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24 Oct 2017

Case Study: US FDA grants of priority review status for Lynparza sNDA

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US FDA grants priority review status for Lynparza sNDA in metastatic breast cancer

AstraZeneca and Merck & Co., have 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. A Prescription Drug User Fee Act date is set for the first quarter of 2018.

This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for Lynparza in the US. The sNDA is based on the positive results from the phase III OlympiAD trial published in the New England Journal of Medicine.

Lynparza was first approved in December 2014 as a capsule formulation, making it the first ever PARP inhibitor to be approved. Since then, Lynparza has been used to treat more than 3,000 advanced ovarian cancer patients. Lynparza tablets are currently being tested in a range of tumour types including breast, prostate and pancreatic cancers.

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