AstraZeneca: priority review for Lynparza
(CercleFinance.com) - AstraZeneca has announced that its supplemental new drug application (sNDA) for Lynparza (olaparib) has been accepted for priority review in the US for the adjuvant treatment of patients with high-risk HER2-negative BRCA-mutated early breast cancer (BRCAm) who have been previously treated with chemotherapy, before or after surgery.
The sNDA was based on results from the OlympiA phase III trial which showed that Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancer or death by 42% compared to placebo.
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