The first submission for a poly ADP-ribose polymerase (PARP) inhibitor in breast cancer in Europe comes from AstraZeneca and Merck.
Following its approval by the US Food and Drug Administration in January 2018 for treatment of BRCA-mutated HER2-negative metastatic breast cancer, LYNPARZA (olaparib) has been accepted for review by the European Medicines Agency (EMA). The Marketing Authorization Application for LYNPARZA was submitted by AstraZeneca and Merck (known as MSD outside the US and Canada) for the treatment of patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
LYNPARZA is a poly ADP-ribose polymerase (PARP) inhibitor. The FDA approval was the first for a PARP in an indication outside of ovarian cancer. The submission to the EMA is the first for a PARP in breast cancer in Europe. The drug is already available in nearly 60 countries and has been used to treat more than 20,000 patients with many different types of cancer, according to a press release by the companies.
Data for the submission was generated in the phase 3 OlympiAD clinical trial, which was designed to evaluate the performance of LYNPARZA against chemotherapy (capecitabine, eribulin, or vinorelbine). The PARP inhibitor was found to significantly prolonged progression-free survival compared with chemotherapy, and reduced the risk of disease progression or death by 42%.