FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer

On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, 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 olaparib in the United States. The sNDA is based on the positive results from the phase III OlympiAD trial published in The New England Journal of Medicine.

About OlympiAD

OlympiAD is a randomized, open-label, multicenter phase III trial assessing the efficacy and safety of olaparib tablets (300 mg twice daily) compared to physician’s choice of chemotherapy (capecitabine, vinorelbine, or eribulin [Halaven]) in 302 patients with HER2-negative, metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The ongoing international trial is being conducted in 19 countries across Europe, Asia, North America, and South America.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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