AstraZeneca has announced that its drug Lynparza has been accepted for European regulatory review in a new breast cancer indication.
The European Medicines Agency has validated the company's marketing authorisation application for Lynparza for use in patients with deleterious or suspected deleterious BRCA-mutated HER2-negative metastatic breast cancer.
“AstraZeneca's Lynparza has been accepted for European regulatory review as a treatment for BRCA-mutated HER2-negative metastatic breast cancer.“
This therapy is intended for patients who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting, and could become the first PARP inhibitor available for breast cancer treatment in Europe if approved.
Data from the phase III OlympiAD trial has shown that Lynparza is able to significantly prolong progression-free survival rates compared with chemotherapy, while reducing the risk of disease progression or death by 42 percent.
It was approved by the US Food and Drug Administration for use in the treatment of this form of breast cancer earlier this year. Lynparza has been made available in nearly 60 countries so far, and has been used to treat more than 20,000 patients.
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