EMA to Decide if Lynparza Can Treat BRCA-mutated Metastatic Breast Cancer Patients

EMA to Decide if Lynparza Can Treat BRCA-mutated Metastatic Breast Cancer Patients
The European Medicines Agency has agreed to review an application by AstraZeneca and MSD requesting the approval of Lynparza (olaparib) for the treatment of patients with a difficult-to-treat type of metastatic breast cancer who previously received chemotherapy. The Marketing Authorization Application for Lynparza is supported by the results of the Phase 3 OlympiAD clinical trial (NCT02000622), which compared the safety and effectiveness of Lynparza tablets (300 mg taken twice daily) to physician's choice chemotherapy — Xeloda (capecitabine), Navelbine (vinorelbine), or Halaven (eribulin). All patients had previously been treated with chemotherapy. The global, multi-center study included 302 patients (205 received Lynparza) who were either triple negative — meaning their cancer did not produce human epidermal growth factor receptor 2 (HER2), estrogen receptors (ER), and progesterone receptors (PR) — or were positive for hormone receptor (HR), which means PR or ER activity. Tests for the presence of these receptors indicates which hormones or other proteins may be promoting the cancer. Treatment with Lynparza decreased the risk of disease progression or death by 42% compared to chemotherapy. It also induced a response in 52%
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