FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EU Approves Lynparza for Treatment of Breast Cancer

April 18, 2019

European regulators approved Lynparza (aloparib), AstraZeneca’s and Merck’s treatment for advanced or metastatic breast cancer.

The European approval was based on positive results from a Phase III trial in 302 cancer patients. The progression-free survival of patients in the Lynparza group improved by 2.8 months, on average, and had more than double the response rate of those patients receiving just chemotherapy.

Lynparza was previously approved for two forms of ovarian cancer. It’s a relatively rapid turnaround for the two pharma giants, who announced their collaboration in 2017.

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