Lynparza Approved in EU to Treat Subset of Advanced Breast Cancer

Lynparza Approved in EU to Treat Subset of Advanced Breast Cancer
Lynparza (olaparib) tablets have been approved by the European Commission as a standalone treatment for adults with a subset of locally advanced or metastatic breast cancer. The decision follows a recommendation by the Committee for Medicinal Products for Human Use (an arm of the European Medicines Agency), making Lynparza available for patients with Stage III or IV breast cancer, whose tumors are human epidermal growth factor receptor 2-negative (HER2-) and positive for BRCA gene mutations. To receive Lynparza under this indication, patients need to have previously received chemotherapy — anthracycline and a taxane — either before or after surgery, unless they're unsuitable for such treatments. Also, patients with hormone receptor (HR)-positive cancer should have been treated with or been considered unsuitable for hormone therapy. Lynparza, developed jointly by AstraZeneca and Merck (known as MSD outside the U.S. and Canada), is a PARP enzyme inhibitor that blocks the DNA repair process in cells. Due to their faster division, cancer cells accumulate errors faster than healthy cells, which, if not repaired, causes their death. The BRCA1 and BRCA2 genes produce proteins involved in DNA repair. When either of these genes is altered, these proteins may not be made or function correctly, which precludes DNA repair and increases the risk for additional genetic changes that can lead to cancer. “With this approval, Lynparza provides patients throughout the EU with a targeted and oral chemotherapy-free treatment option for a difficult-to-treat cancer,” Dave Fredrickson, AstraZeneca’s executive vice president of oncology, said in a press release. He added that this decision “reinforces the importance of testing for biomarkers including BRCA,
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