AstraZeneca's Lynparza Granted Priority Review In U.S. For High-risk Early Breast Cancer

(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) said that its supplemental New Drug Application or sNDA for Lynparza or olaparib has been granted Priority Review in the US for the adjuvant treatment of patients with BRCA-mutated or BRCAm HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the first quarter of 2022.

Lynparza is being jointly developed and commercialized by AstraZeneca and Merck & Co., Inc.

The sNDA was based on results from the OlympiA Phase III trial. The results showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo.

Lynparza is approved in the US, EU, Japan and several other countries for the treatment of patients with germline BRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial. In the EU, this indication also includes patients with locally advanced breast cancer.