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EMA to Review Olaparib in BRCA-mutated, HER2-negative Breast Cancer

Jason Harris
Published: Tuesday, Apr 03, 2018

breast cancer
The European Medicines Agency has accepted a marketing authorization application for olaparib (Lynparza) to treat women with BRCA-mutated, HER2-negative metastatic breast cancer who previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.

Merck (MSD) noted in a press release that this is the first time an approval has been sought in Europe for a PARP inhibitor in breast cancer. The company entered an agreement with AstraZeneca in July 2017 to jointly develop olaparib. The US FDA approved olaparib in this setting based on the same data in January of this year.
Robson M, Im SA, Senkus E, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. 2017;377:523-33. N Engl J Med. doi: 10.1056/NEJMoa1706450.

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