- AstraZeneca (NASDAQ:AZN) and Merck (MRK) announces that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for LYNPARZA (olaparib) for use in patients with BRCA-mutated, HER2-negative metastatic breast cancer, previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
- If Approved, AstraZeneca and Merck’s LYNPARZA would be the first PARP inhibitor to treat patients with breast cancer in Europe.
- The MAA is based on data from the OlympiAD trial, which investigated LYNPARZA versus chemotherapy.
- LYNPARZA is the PARP inhibitor and the first targeted treatment to potentially exploit DNA damage response pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.